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Our client is seeking a skilled Regulatory Affairs Specialist to support the planning, coordination, and execution of regulatory strategies for medical products requiring government approval. This role is ideal for a detail-oriented individual with in-depth regulatory knowledge and proven experience preparing submissions of basic to medium complexity.
Key Responsibilities:
- Develop and implement regulatory strategies to support product submissions and approvals
- Prepare, review, and submit regulatory documentation in accordance with applicable regulations and guidelines
- Interpret and apply relevant healthcare regulations and statutes to ensure compliance
- Translate complex technical data into clear, concise, reviewer-friendly content
- Collaborate with cross-functional teams to refine and validate submission data
- Serve as a liaison with regulatory authorities to support product clearance or approval processes
- Ensure submissions meet all applicable regulatory requirements and internal quality standards
- Contribute to the strategic direction of regulatory pathway development for assigned products
- Act as a resource and mentor for junior regulatory colleagues
Qualifications:
- Bachelors degree in life sciences, engineering, or a related field (advanced degree preferred)
- 5+ years of experience in Regulatory Affairs within the medical device, diagnostics, or healthcare industry
- Strong working knowledge of FDA, EU MDR/IVDR, and other international regulatory requirements
- Demonstrated success in preparing and managing regulatory submissions
- Experience interacting with regulatory bodies (e.g., FDA, Notified Bodies)
- Familiarity with submission types such as 510(k), PMA, CE Mark, Technical Documentation
- Understanding of competitive products and evolving regulatory landscapes
Seniority level
Seniority level
Entry level
Employment type
Employment type
Contract
Job function
Job function
Consulting-
Industries
Medical Equipment Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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