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Senior Regulatory Affairs Specialist - Biosense Webster, Inc.
Johnson & Johnson - Cheyenne, WY
posted about 2 months ago
About the position
The Senior Regulatory Affairs Specialist at Biosense Webster, Inc. is responsible for developing regulatory submissions and assessments to ensure the timely global commercialization of medical devices. This role involves authoring regulatory documents, preparing international documentation, and communicating with regulatory agencies. The position requires a strong understanding of applicable regulations and standards, as well as the ability to evaluate product changes and participate in new product development teams.
Responsibilities
- Develop and implement regulatory strategies and processes for global commercialization of products.
- Author regulatory submissions and assessments for class II and III medical devices for the US market.
- Author technical documents for products intended for the EU market.
- Prepare international documentation to support product registration.
- Communicate directly with FDA and other regulatory agencies regarding submissions and audits.
- Evaluate proposed changes to product design or manufacturing processes for regulatory impact.
- Participate in new product development teams and review product documentation.
- Write, review, and revise company SOPs as required.
- Communicate business-related issues or opportunities to management.
- Ensure compliance with all applicable regulations and company policies.
Requirements
- BS degree in Engineering, Physical or Biological science with a minimum of 3 years of experience in Regulatory Affairs or related discipline, or an advanced degree with 2 years of experience.
- Familiarity with MS Office applications.
- Excellent verbal and written communication skills.
- Project management skills.
- Problem-solving skills.
- Presentation skills.
- RAC Certification preferred.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short- and long-term disability insurance
- Business accident insurance
- Group legal insurance
- 401(k) retirement plan
- Pension plan
- Vacation time (up to 120 hours per year)
- Sick time (up to 40 hours per year)
- Holiday pay (up to 13 days per year)
- Floating holidays (up to 40 hours per year)
