(Only 24h Left) Regulatory Affairs Associate

2 days ago

Delhi, India BioTalent Search Private Limited Full time
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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