Hybrid Regulatory Affairs Specialist II – Power Tools, Orthopaedics

at OneTrust

• Job title: Regulatory Affairs Specialist II – Power Tools, Orthopaedics
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Zuchwil, Switzerland

About the role

• Regulatory Affairs Specialist II providing regulatory guidance to project teams in Orthopaedics at Johnson & Johnson. Responsible for developing and executing regulatory strategy for product approvals.

Responsibilities

• 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.
• Provides key deliverables in a timely manner and in accordance with project team expectations and regulatory project plan timelines (e.g., regulatory strategy, regulatory change assessment, etc.)
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.
• Conduct regulatory promotional labeling and marketing compliance reviews ensuring activities and communications are consistent with product labeling, are adequately supported and are following applicable laws, regulations and policies related to advertising & promotion of regulated products.
• Represents Regulatory Affairs on cross-functional project teams and provides regulatory guidance.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Provide 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.
• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.

Benefits

• Professional development opportunities