Senior Regulatory Affairs Specialist
A growing medical device company is seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy and submissions across a diverse product portfolio. This role will partner cross-functionally with quality, clinical, and product development teams to ensure compliance with applicable regulations throughout the product lifecycle.
Key Responsibilities
- Support development and execution of regulatory strategies for new and existing products
- Prepare, review, and submit regulatory filings (e.g., 510(k), EU Technical Documentation, and other global submissions)
- Interface with regulatory agencies and notified bodies as needed
- Ensure compliance with FDA, EU MDR, and other applicable global regulations
- Provide regulatory input to cross-functional teams during product development and change management activities
- Support labeling, claims, and promotional review processes
- Maintain regulatory documentation and contribute to internal audits and inspections
Qualifications
- Bachelor's degree in a scientific, engineering, or related field
- 5+ years of experience in Regulatory Affairs within the medical device industry
- Working knowledge of U.S. and international regulatory requirements
- Experience supporting submissions and interacting with regulatory agencies is preferred
- Strong communication and cross-functional collaboration skills
Additional Information
- Exposure to a range of product types and regulatory pathways is beneficial
- Ability to manage multiple projects in a fast-paced environment
- Advanced degree or RAC certification is a plus
This is an opportunity to contribute to a dynamic team supporting innovative medical technologies while maintaining a broad scope of regulatory responsibility.
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