BioTalent Search Private Limited | Regulatory Affairs Associate
23 hours ago
Job Title: Regulatory Affairs Associate
Location: Bengaluru
Education:
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.
Experience:
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.
Technical Expertise:
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.
Responsibilities:
Regulatory Compliance & Certification:
Plan and manage medical device testing to ensure compliance with ISO 13485, IEC 61326 (EMC), and IEC 61010 (Safety) standards.
Prepare and maintain Medical Device Files (MDF) for regulatory submissions (CDSCO, CE IVDR, and FDA).
Draft and oversee the creation of Technical Files, Risk Management Plans, Clinical Evaluation Reports (CER), and Design History Files (DHF).
Lead regulatory submission processes, including 510(k) or De Novo filings for FDA and CE Marking under IVDR.
Serve as the primary liaison with notified bodies, regulatory agencies, and external auditors.
Quality Control Systems:
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.
Cross-Functional Collaboration:
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.
Project Management:
Define and track milestones for device certification and regulatory approval processes.
Manage project timelines, allocate resources, and oversee dependencies across teams.
Identify potential risks in regulatory and certification processes and implement mitigation strategies.
Risk and Safety Management:
Conduct comprehensive Risk Assessments and develop Risk Management Plans in alignment with ISO 14971.
Ensure compliance with safety and performance standards throughout the product lifecycle.
Soft Skills:
Strong project management skills, with the ability to manage timelines and cross-functional teams.
Excellent communication and documentation skills, with attention to detail.
Proactive problem-solving ability and an aptitude for managing complex regulatory requirements.
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