Senior Regulatory Affairs Specialist in Ultrasound focusing on regulatory submissions and product clearances. Collaborating with regulatory authorities to ensure compliance and timely product development.
About the role
- Regulatory Affairs Specialist II providing regulatory guidance for Orthopaedics Velys power products at Johnson & Johnson. Focus on compliance and regulatory strategy execution.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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