Regulatory Affairs Expert
3 days ago
We are seeking a seasoned Regulatory Affairs expert to join our team at BioTalent Search®. As a key member of our organization, you will be responsible for ensuring the compliance of our medical devices with international regulatory standards.
Salary:$100,000 - $120,000 per annum (dependent on experience)
About the Role:
In this role, you will plan and manage medical device testing to ensure compliance with ISO 13485, IEC 61326 (EMC), and IEC 61010 (Safety) standards. You will also prepare and maintain Medical Device Files (MDF) for regulatory submissions (CDSCO, CE IVDR, and FDA).
You will lead regulatory submission processes, including 510(k) or De Novo filings for FDA and CE Marking under IVDR. Additionally, you will serve as the primary liaison with notified bodies, regulatory agencies, and external auditors.
Responsibilities:
- Design and implement robust Quality Control (QC) systems for scalable hardware manufacturing
- Develop and manage protocols for Incoming Material Inspection (IMI), In-Process QC, and Final Product QC
- Monitor QC data and drive continuous improvements in manufacturing processes
- Establish and oversee a supplier qualification program, including supplier audits and quality agreement management
- Collaborate with R&D, manufacturing, and design teams to embed regulatory and quality considerations in product development
- Train internal teams on regulatory and quality requirements to ensure organization-wide compliance
- Stay updated on evolving regulatory landscapes and communicate changes to relevant stakeholders
Requirements:
- Bachelor's or Master's degree in Engineering, Biomedical Sciences, or a related discipline
- Certifications in regulatory compliance or quality systems (e.g., RAC, CQE) are a plus
- Minimum 3-4 years of experience in medical device testing, regulatory compliance, or quality systems management
- Proven track record of achieving CE Marking and FDA certification for medical devices
Key Skills:
- Proficiency in IEC 61326, IEC 61010, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards
- Familiarity with ISO 13485 and ISO 14971
- Hands-on experience with Medical Device File preparation and submission processes
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