Senior Compliance Manager
Grafana Labs
ERP
Senior Regulatory Affairs Specialist
Meridian Bioscience Inc.
full-time
Posted on:
Location: Ohio • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Provides support and guidance to quality and regulatory activities, including Design Control activities, project teams, design transfer activities, clinical trials, validation and verification activities, and existing product modifications.
- Supports and helps draft sections of regulatory submissions for domestic, world-wide commercialization and other business objectives.
- Drafts, evaluates, and reviews technical protocols and data in support of clinical trials, validation, verification and product manufacturing.
- Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
- Evaluates the regulatory impact of changes associated with product design change and routine change control.
- Drafts and reviews, and helps provide guidance for product labeling activities, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
- Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
- Compiles new product technical information and feature summaries in support of market expansion.
- Responds to Sales & Marketing requests to ensure content of collateral and promotional materials is compliant with applicable regulations.
- Participates in long-term projects supporting the business and quality objectives of the organization.
- Assists in the management of third party and internal Quality Audit programs; perform supplier audit and verification activities as directed.
- Other duties as assigned.
Requirements
- Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
- A minimum of 4 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.
- Prior experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent.
- Competencies Required or preferred Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971).
- Experience with design, development, and clearance of medical devices.
- Demonstrated strong leadership, project management and organizational skills.
- Highly motivated, detail oriented, must have a constant awareness of customer requirements and must demonstrate an ability to make fact- driven decisions; maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, ISO13485, 98/79 EC, and SOR/98-282
- Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.
- Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
- Must possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.
- Ability to speak in large groups and actively engage participants.
- Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook).
