BioTalent Search Private Limited | Regulatory Affairs Associate | india
2 days ago
We are hiring for our rapidly growing client in the biotech IVD manufacturing business, based in Bengaluru.
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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