Regulatory Affairs Associate

4 weeks ago

Bengaluru, India BioTalent Search® 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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