Director, Quality & Regulatory Affairs
INSIGHTEC
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- Serve as US Agent and Official Correspondent for Insightec
- Develop and lead clinical regulatory strategies for Class II and Class III medical devices from early development through market approval.
- Interpret and apply complex regulatory and quality requirements to clinical trial planning and execution, and ensure submissions meet the latest regulatory requirements and are completed on schedule.
- Review and submit high-quality clinical regulatory documentation, including new and subsequent supplements for IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, prepare and submit clinically relevant Design/SW changes.
- Ensure compliance with applicable clinical trial regulations (e.g. 21 CFR 812, ICH-GCP, MDR, ISO 14155) and quality management system requirements medical devices (e.g. 21 CFR 820, ISO 13485, ISO 14971, IEC, etc.).
- Lead and prepare teams for pre-submission meetings, advisory panels, regulatory pathway submissions, and clinical related inspections (e.g. FDA BIMO Inspections).
Requirements
- Bachelor's degree in life science or related field required; advanced degree preferred.
- 8-10 years of clinical regulatory affairs experience in the medical device industry, with at least 5 years in a leadership capacity.
- Deep knowledge and hands-on experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions.
- Proven experience interacting with FDA and other global regulatory bodies on clinical issues.
- Strong understanding of clinical trial design, statistical principles, and regulatory and quality requirements for high-risk medical devices.
Benefits
- flexible work environment
- competitive perks and benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical regulatory strategiesregulatory documentationclinical trial planningIDE/IND submissionsITA/CTA submissionsEU CTAsPMA submissions510(k) submissionsDesign/SW changesclinical trial design
Soft Skills
leadershipcommunicationteam preparationinterpersonal skillsorganizational skills