Penumbra, Inc.

Compliance

• Prepare complex submissions with supervision to gain approvals for commercial distribution for countries in their sphere of responsibility.
• Communicate with regulatory authorities, regulatory consultants, and distributors to facilitate registration as deemed necessary.
• Perform the following activities in support of submissions: research, identification of filing regulations, correspondence, scheduling, tracking, trending analysis, translation support, filing preparation and document maintenance for compliance with U.S. and international regulatory requirements.
• Track and ensure that existing product registrations are maintained and updated as required.
• Review and approve advertising/promotional materials and procedures to ensure regulatory compliance.
• Review and approve product and manufacturing changes and shipping release documents for compliance with applicable regulations.
• Provide interpretation of region-specific Regulatory Authority regulations and guidelines as needed to support accomplishment of organizational objectives. Maintain up-to-date understanding of current and new regulatory requirements in existing markets and proactively identify regulatory requirements in prospective markets.
• Assist with Customs/Importation procedures to ensure timely movement of product.
• Partner with cross-functional team members to ensure that regulatory strategies are compliant, aligned with business objectives, and incorporated into the appropriate product development project phases.
• Assist in activities (e.g., execution, documentation) related to Field Corrective Actions.
• Participate in internal and external audits, including the monitoring and tracking of open non-conformances and observations.

Regulatory Affairs Specialist – APAC

Account Manager

• Ausbau und Weiterentwicklung des Vertriebsgebiets, von der Gewinnung neuer Kund*innen bis zur Betreuung bestehender Accounts
• Unterstützung von interventionell tätigen Ärzt*innen direkt vor Ort, z.B. bei Schulungen, Produktvorführungen und während Operationen
• Erkennen von Chancen im Gebiet und Umsetzung von Maßnahmen zur Umsatzsteigerung
• Zusammenarbeit mit Marketing, Innendienst und europäischen Kolleg*innen, um Initiativen gut abzustimmen
• Insights aus dem Gebiet sammeln, analysieren und daraus Maßnahmen ableiten

Territory Manager Neurovascular - Ostdeutschland

Operations

• Provide front-line support for Sales Representatives and serve as an in-house resource for the entirety of our sales operation.
• Review, analyze, and process complex orders as they pertain to, but not limited to, Travel Stock Usage, Discounts, Bulk Buy, Special Offers, etc.
• Contract/Letter review as they pertain to special offer orders or volume discounts.
• Coordinate with multiple departments for appropriate review and/or approval.
• Coordinate and process orders for shipment and billing of product used, supporting our Travel Stock Program.
• Ensure compliance with company policies and procedures.
• Review and resolve a variety of transactions as they pertain to different process areas.
• Document usage and billing activities in accordance with company requirements.
• Identify inventory and order-related discrepancies, initiate investigation and effectively resolve minor errors or escalate as necessary.
• Serve as primary back-up to Order Processing.
• Generate and process Returned Material Authorizations (RMAs) via RMA/Complaint Reporting and ERP systems with a primary focus on Complaint RMAs.
• Respond to general requests related to order fulfillment and product inquiry, providing product description/overview or assistance in product selection as required.
• Work directly with internal and external departments to build productive working relationships to effectively resolve issues including those related to discrepancies in orders, inventory, returns and billing.
• File customer complaints in accordance with complaint handling procedures.
• Comply with regulations, QMS standards and procedures, and SOX.
• Log metrics data for quality purposes.
• Maintain excellent customer and sales relations.
• Support various time zones as assigned.
• Work company holidays as business needs necessitate.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Field Support Operations Representative I

• Expand and strategically develop the sales territory – from acquiring new customers to the long-term management of existing accounts
• Advise and actively support interventional physicians directly in the clinical environment, including trainings, product demonstrations and OR support
• Identify opportunities within the territory and implement targeted measures to increase revenue
• Work closely with marketing, inside sales and European colleagues to optimally coordinate initiatives
• Capture field intelligence, analyze it and translate findings into strategic actions for the territory

Territory Manager Neurovascular, Southwest Germany

Medical writer

• Prepare high-quality abstracts and presentations for submission and presentation at conferences.
• Engage in scientific writing and/or edit manuscripts for submission to peer-reviewed journals to achieve publication goals.
• Ensure scientific communication deliverables are completed in a timely manner.
• Evaluate data and translate information into succinct, scientific summaries.
• Collaborate cross-functionally with clinical, marketing, and creative teams to ensure data dissemination goals and deadlines are met.
• Work with clinical study management and statistics teams to create timelines for completing data dissemination plans related to clinical studies.
• Strong communication with physician authors to achieve deliverables, maintain relationships, and to facilitate overall scientific communication efforts.
• Contribute to the preparation of clinical data for analysis and scientific writing.
• Conduct literature searches for relevant disease states and maintain the clinical literature library.
• Lead cross-functional project reviews and serve as a core team member and subject matter expert on clinical study teams to create timelines for completing medical writing documents.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.
• *Indicates an essential function of the role

Medical Writer, Scientific Communications

Project Manager

• Evaluate and proactively identify updates needed within the existing QMS processes, policies, and procedures to meet evolving regulatory requirements and business needs.
• Partner with business stakeholders to identify process challenges and develop solutions, including eQMS driven solutions.
• Collaborate with stakeholders to gather critical information for prioritizing project requests.
• Resolve ambiguous requirements through structured discussions, and translate them into clear, comprehensive business requirements document, aligned with stakeholder objectives.
• Partner with cross-functional teams and act as a driver for collaboration, ensuring alignment across departments and fostering a cooperative environment to achieve project goals.
• Establish clear roles and responsibilities with cross-functional team members to promote accountability, streamline workflows, and ensure successful project execution.
• Design and document process workflows that align with regulatory requirements and business objectives.
• Lead cross-functional efforts with Subject Matter Experts (SMEs) to assess, revise, and implement quality processes and procedures.
• Design and manage complex project plans, setting strategic milestones, allocating resources, deliverables, and compliance activities to meet stakeholder expectations.
• Independently lead and manage QMS improvement initiatives from concept through execution, ensuring successful project delivery that aligns with regulatory compliance requirements, internal policies, and industry standards.
• Maintain oversight to ensure all projects adhere to relevant regulations, internal quality policies, and standards throughout all project phases, mitigating compliance risk.
• Serve as a key contributor to audit readiness, prepare for, and participate in external audits by regulatory authorities.
• Establish clear communication channels for reporting project status, to ensure visibility of project progress, risks, and key decisions to both the project team and management.
• Influence stakeholders through data-driven insights and compliance knowledge expertise, to ensure project alignment, resolution of compliance gaps, and seamless execution.

Project Manager, Quality & Compliance

Therapist

• Drive downstream execution for U.S. marketing and Venus Thromboembolism Education (VTE) initiatives within a target region.
• Act as a regional VTE care path expert, driving improved care path knowledge across the regional teams you support while supporting a broad coalition of customers.
• Must be able to prioritize key account work across multiple regions.
• Develop and execute education and clinical care path strategies, drive (or support) clinical program development plans through innovative field education programs.
• Manage account education initiatives throughout the project lifecycle and effectively communicate with regional sales team throughout.
• Identify and develop care path KOL’s and educational program opportunities to utilize.
• Identify, organize, and execute local/regional care path tradeshows & conferences and other meetings to optimize product and therapy awareness regionally.
• Represent marketing as key point of contact within a defined Sales region.
• Work closely with field sales leaders, sales, and clinical teams.
• Assist with local PR initiatives related to the launch of products working with hospital marketing, Penumbra product marketing, and Penumbra communications team to drive therapy awareness in local market.
• Drive understanding of patient & clinician insights within the therapy, including patient and care path physician behavior.
• Establish and foster relationships with key customers and key opinion leaders within assigned region to enable podium representation of Penumbra products and to ensure that launches and programs are relevant to drive understanding and adoption of related products.
• Promote and maintain the Penumbra brand raising therapy awareness within assigned region.
• Collect and share intelligence with manager on relevant competitive products, activities, and/or therapies for competitive products.

Therapy Development Specialist – Southeast

Risk

• Design and implement RBQM strategies in accordance with TransCelerate’s methodology, including risk assessment, risk control, risk review, and risk reporting.
• Lead cross-functional teams in the development of study-specific Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk mitigation plans.
• Facilitate initial and ongoing risk assessments using tools such as RACT (Risk Assessment Categorization Tool).
• Ensure integration of RBQM principles into protocol design, monitoring plans, and data management strategies.
• Develop and manage centralized monitoring processes to identify data trends, anomalies, and potential risks across clinical sites.
• Collaborate with data management and biostatistics teams to define algorithms and dashboards for real-time data visualization and risk detection.
• Interpret centralized monitoring outputs to guide targeted site monitoring and recommend corrective actions.
• Serve as a subject matter expert (SME) for RBQM and centralized monitoring across clinical development teams.
• Provide training and guidance to internal stakeholders on RBQM principles and tools.
• Partner with Clinical Operations and Clinical Quality to ensure compliance with ICH E6(R2), GCP, and regulatory expectations.
• Monitor industry trends and regulatory updates related to RBQM and centralized monitoring.
• Evaluate and implement technology solutions that enhance risk detection and oversight capabilities.
• Contribute to internal audits and inspection readiness activities related to RBQM and centralized monitoring.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Risk-Based Quality Management (RBQM) Specialist – Temporary

• Conduct prompt and appropriate investigations in response to complex employee relations concerns
• Apply investigation best practices, interviewing and documentation techniques
• Synthesize and analyze complex facts, witness statements, documents, and data to draw well-supported conclusions and assess credibility
• Draft investigative reports with objective, impartial findings and supporting documentation
• Communicate effectively across all employee levels, various geographic boundaries and cultural differences
• Set realistic expectations with internal teams
• Manage and assist with other employee relations concerns
• Develop, enhance, or recommend resources and tools to aid management and HR in employee relations
• Provide reports and analyze employee relations trends to business leaders and HR teams

Employee Relations Manager

Customer Support

• Lead and coordinate the daily operational activities of your team, ensuring expected performance levels are consistently met
• Foster a culture of operational excellence — optimizing workflows, balancing workloads, and ensuring adherence to procedures
• Provide hands-on support and guidance, acting as a subject matter expert and trusted advisor to the team
• Be fully operational yourself — capable of taking over tasks and ensuring business continuity when needed
• Coach, motivate, and develop team members to achieve their full potential and deliver outstanding service
• Collaborate with internal stakeholders (Sales, Supply Chain, Finance, etc.) to ensure efficient order-to-cash (OTC) processes and smooth communication
• Identify and drive process improvements to increase efficiency and service quality
• Manage escalations within your operational scope, resolving issues quickly

Customer Service Supervisor

Accounts Payable

• Manage invoice processing, payments, and reconciliations, ensuring everything is accurate and on time.
• Be the go-to person for vendor and stakeholder questions or escalations, resolving issues quickly and professionally.
• Keep vendor data accurate and up to date, and ensure compliance with audit and control standards.
• Support month-end closing and reporting activities.
• Suggest improvements and help make AP processes more efficient, including supporting new tools or automation initiatives.
• Mentor and support junior AP colleagues, sharing knowledge and best practices.

Senior Accounts Payable Specialist – f/m/d

• Manage and grow customer relationships in the field of peripheral vascular interventions, with a focus on delivering clinical value and long-term partnership.
• Identify new business opportunities and execute territory growth strategies across hospitals and clinics.
• Support physicians during PV procedures by providing in-depth product knowledge and guidance in the operating room.
• Deliver hands-on product training and education to ensure safe and effective use.
• Serve as the key contact for all PV-related inquiries, maintaining a high level of responsiveness and service.
• Monitor customer stock levels and coordinate with internal teams to ensure timely product availability.
• Document territory activities and progress in the CRM system, and provide regular performance updates.
• Attend industry events, workshops, and customer meetings relevant to the peripheral vascular space.

Territory Manager, Peripheral – West Poland

Manager

•Partner effectively across the business (Market Access Managers, Product Marketing, Therapy Development, Strategic Accounts, Medical Education, Reimbursement, Corporate Strategy, Sales Leadership and field Clinical Specialist teams) to drive strategies and adapt/localize health economic models, value analysis, and clinical evidence to address hospital systems’ specific health economics and care pathways (including outcomes research).
•Proactively monitor the external environment, customers, and competitors to identify opportunities for expanding market access and regularly measure success of implementation through analysis and tracking of goals, accomplishments, and business impact.
•Assist in developing strategies, roadmap, and vision for appropriate engagement with hospital executives and administrators, establishing constructive relationships and long-term plans for partnering with Penumbra.
•Understand, advance, and support Company policies and priorities, including healthcare compliance principles and the Company’s Compliance Program; ensure employees reporting to this role follow these policies.
•Represent Penumbra externally and adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
•Understand relevant security, privacy and compliance principles and ensure department adherence to applicable regulations, standards, and procedures.
•Perform other work-related duties as assigned

Manager, Hospital Engagement

Accountant

• General Summary Reporting to the Accounting Manager, the Senior Accountant - T is responsible for portions of the monthly general ledger close, balance sheet and income statement analysis. This role requires working from the Alameda office. We anticipate this role will last approximately 8 weeks.
• Specific Duties and Responsibilities
• Prepare General Ledger entries and reconciliations of accounts for monthly close.
• Assist with SOX control monitoring and adherence.
• Provide support during external financial audits and help manage audit coordination.
• Perform monthly account reconciliations.
• Prepare monthly financial statements and variance analysis for management review.
• Review staff accountant journal entries and account reconciliations as needed.
• Assist with special projects assigned by management.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.
• Indicate that an essential function of the role
•
• Required Qualifications
• Minimum education and experience:
• Bachelor''s degree in accounting, finance or similar, with 5+ years of relevant experience or an equivalent combination of education and experience
• Experience working in SAP or another large ERP system
• Knowledge of generally accepted accounting practices and principles

• Preferred Qualifications:
• CPA
• Experience working in a publicly traded company
• Knowledge of auditing practices and principles
• Experience in medical device or a related industry is a plus

• Working Conditions
• General office environment
• Requires some lifting and moving of up to 25 pounds
• Must be able to remain stationary and use a computer to read, prepare emails, and produce documents and spreadsheets for an extensive period each day
• Must be able to move between buildings and floors within the office and access file cabinets or supplies, as needed
• Must be able to communicate and exchange accurate information with employees at all levels daily

• Base Pay Range Per Hour: $50.00 - $65.00