Sr. Regulatory Affairs Specialist
Contract role
Houston - Hybrid
Must have Regulatory experience within the Medical Device industry
PRIMARY ACTIVITIES
- Preparing regulatory submissions (510(k); IDE; IDE Supplements; PMA; PMA Supplements, CE Marking, etc.) for submission to the FDA and International Regulatory Agencies.
- Interfacing with the Regulatory Agencies on assigned projects.
- Responding to Regulatory Agencies requests for additional information.
- Submitting Export Clearance requests or simple export notifications to FDA per the FD&C Act, Sections 801(e) or 802.
- Interacting with the FDA and International Regulatory Agencies during quality inspections. Responsible for responding to requests for special reports during such inspections.
- Keeping abreast of changes to the worldwide regulatory requirements and International Standard related to our products and processes.
- Formally communicating regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations.
- Reviewing QSR documentation for assigned projects to insure compliance with QSR and determining whether regulatory submissions are required.
- Overseeing maintenance of regulatory files to ensure the Company’s compliance with regulatory requirements.
- Performing other duties as may be required by management
EXPERIENCE AND DESIRED SKILLS
- Must have 2+ years of experience in RA within Medical Devices
- Familiarity with U.S. and foreign country regulatory requirements and submissions.
- Excellent verbal and written communication skills, analytical skills, teamwork and interpersonal skills.
- ISO 9000 / QSR experience.
- Prior employment with FDA.
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