Stryker

Senior Regulatory Affairs Specialist, RA

Stryker

part-time

Posted on:

Location Type: Hybrid

Location: Selzach • 🇨🇭 Switzerland

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • The Senior Regulatory Affairs Specialist you will work to bring medical devices to market and ensures ongoing compliance.
  • You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interacts with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluates proposed device changes.
  • Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
  • Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature .
  • Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
  • Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
  • Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
  • Evaluate proposed products for regulatory classification and jurisdiction.
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
  • Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
  • Negotiate with regulatory authorities throughout the product lifecycle.
  • Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Assist other departments in the development of SOPs to ensure regulatory compliance.
  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
  • Advise stakeholders of regulatory requirements for quality, pre-clinical, and clinical data to meet applicable regulations.
  • Assess the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations.
  • Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
  • Provide knowledge and guidance on pre-approval inspections, GCP inspections, and clinical investigator relationships.
  • Identify, monitor and submit applicable reports or notifications to regulatory authorities during the clinical research process.
  • Provides regulatory information and guidance for proposed product claims/labeling.
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

Requirements

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
  • A minimum of 2 years of experience in an FDA or highly regulated industry required.
  • A minimum of 1-2 years in a Regulatory Affairs role required.
  • Previous experience with Class II/III medical devices preferred.
  • Previous experience drafting 510(k)s preferred.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Experience authoring regulatory submissions for product approval preferred.
  • Experience interacting with regulatory agencies preferred.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Excellent analytical and writing skills.
  • Excellent interpersonal, written and oral communication skills.
  • Effective organizational skills.
  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
Benefits
  • Work Flexibility: Hybrid or Onsite

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory submissionsregulatory strategyregulatory complianceregulatory classification510(k) draftingclinical data evaluationpre-clinical data evaluationmanufacturing changes evaluationSOP developmentregulatory filing solutions
Soft skills
analytical skillswriting skillsinterpersonal skillsoral communication skillsorganizational skillsindependent judgmentproblem-solvingprioritizationadvocacycross-functional collaboration
Certifications
RAC certificationMasters in Regulatory Affairs