Regulatory Affairs Specialist II – Power Tools, Orthopaedics
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Zuchwil • 🇨🇭 Switzerland
Visit company websiteJob Level
JuniorMid-Level
About the role
- Provides regulatory guidance to project teams in strategic planning and related submissions to support Orthopaedics Velys power products
- Develops and executes regulatory strategy for significant change supplements and 510(k) registrations
- Ensures compliance with regulatory agency regulations and interpretations
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
- Prepares responses to regulatory agencies' questions and other correspondence
- Researches and collects data; and responds to requests from regulatory agencies and/or distributors
- Advises on regulatory labeling requirements specifications for modified products
- Represents Regulatory Affairs on cross-functional project teams and provides regulatory guidance
- Provides Regulatory Affairs support during internal and external audits
Requirements
- Minimum of a Bachelor’s Degree required ; Advanced Degree strongly preferred
- At least 2+ years of professional regulatory experience in a highly regulated industry required, preferably in medical device ( 1+ years with Advanced Degree )
- Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required
- Experience in the preparation and submission of U.S. regulatory filings (e.g., 510(k), PMA) as well as European technical documentation reports files is strongly preferred
- Knowledge of U.S. and European regulatory processes is preferred
- Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy510(k) registrationPMA preparationU.S. regulatory filingsEuropean technical documentationregulatory compliancedata collectionregulatory labeling requirementsaudit supportregulatory guidance
Soft skills
problem solvingindependent workteam collaborationcommunicationintellectual capacityattention to detailadaptabilitycritical thinkingresearch skillsinterpersonal skills
Certifications
Bachelor’s DegreeAdvanced Degree