Strategic Regulatory Compliance Professional
3 days ago
Boston Scientific is seeking an experienced Regulatory Affairs Specialist to join our team. This individual will play a crucial role in ensuring compliance with regulatory requirements and facilitating the development of medical devices.
Key Responsibilities:
- Provide regulatory support for product development, submissions, and compliance
- Act as a company representative, developing relationships with device reviewers and providing strategic guidance
- Assist with departmental policy and procedure implementation
- Generate and implement regulatory strategies for new and modified medical devices
Required Skills and Qualifications:
- Level 8 Bachelor's Degree in STEM (regulatory affairs or relevant discipline)
- Minimum of 7 years experience in Regulatory Affairs or a related field within the medical device industry
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices
- Prior experience with various regulatory submissions for US and EU MDR
- Excellent oral/written communication skills and ability to articulate ideas
Benefits:
Boston Scientific offers a dynamic work environment, opportunities for professional growth, and a commitment to diversity and inclusion.
About Boston Scientific:
We are a leading global medical technology company dedicated to advancing science for life. Our mission is to improve patient lives through innovative medical solutions.
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