Principal Regulatory Affairs Specialist

📋 Description

• Acting as the lead for regulatory affairs within cross-functional teams.

• Steering regulatory strategy and execution for Tier 1, high-volume markets.

• Performing global assessments of regulatory changes.

• Leading or assisting with regulatory submissions for continuity and lifecycle projects.

• Offering regulatory review and insights on technical documentation and reports.

• Conveying regulatory results and technical information to cross-functional teams.

• Aiding in risk management, vigilance reporting, and other quality-related initiatives.

• Assisting in the implementation of significant corporate initiatives and enabling tools.

⛳️ Requirements

• A Bachelor’s Degree or higher (must be completed and verified prior to start).

• A minimum of ten (10) years of experience in regulatory affairs within the drug and/or medical device sectors.

• Proven experience in authoring regulatory submissions and technical documentation for drug and medical device products.

• Experience in supporting regulatory activities across EMEA, APAC, and LATAM regions.

• Familiarity with revising, reviewing, and approving product labeling, including marketing claims.

• Experience with dental products, encompassing NDA and OTC monograph drugs as well as medical devices.

• Background in supporting design control verification and validation activities for medical devices.

• Ability to apply regulatory knowledge in cross-functional project management.

🏝️ Benefits

• Medical, Dental & Vision coverage.

• Health Savings Accounts.

• Flexible Spending Accounts for Health Care & Dependent Care.

• Disability Benefits.

• Life Insurance.

• Additional Voluntary Benefits.

• Paid Absences.

• Retirement Benefits.