Senior Medical Device Regulatory Specialist
6 days ago
Cedent Consulting Inc. is seeking an experienced Senior Medical Device Regulatory Specialist to join our team in Dallas, TX.
Job DescriptionRegulatory Expertise
The ideal candidate will have a minimum of 3 years of experience in regulatory affairs within the medical device industry, with a focus on preparing submissions, maintaining compliance, and providing strategic advice to internal stakeholders. We are looking for someone with extensive knowledge of global regulations (FDA, EU MDR, Health Canada, TGA, etc.) and international market access strategies.
Main Responsibilities
- Regulatory Strategy Development: Develop and implement regulatory strategies for medical devices, ensuring compliance with global regulations.
- Regulatory Submissions & Documentation: Prepare and review regulatory submission documents, including 510(k) notifications, PMA applications, CE technical files, clinical evaluation reports (CERs), and other regulatory filings for various markets.
- Device Classification & Risk Assessment: Work with cross-functional teams to classify devices according to relevant regulatory frameworks.
- Compliance and Quality Systems: Ensure company's products meet all regulatory requirements, including adherence to quality management standards such as ISO 13485 and FDA QSR (Quality System Regulations).
Requirements
- Education: Bachelor's degree in Life Sciences, Engineering, or a related field (required). Advanced degree (e.g., Master's, PhD, or Regulatory Affairs Certification (RAC)) is a plus.
- Experience: Minimum of 3 years of experience in regulatory affairs, specifically within the medical device industry. Experience with both Class I, II, and III devices is preferred.
- Technical Skills: In-depth knowledge of regulatory requirements for medical devices (FDA, EU MDR, Health Canada, etc.). Familiarity with ISO 13485 and other quality management system standards.
Salary Estimate: $120,000 - $150,000 per year, depending on qualifications and experience.
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