Regulatory Affairs Specialist
21 hours ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bengaluru. As a key member of our organization, you will play a vital role in ensuring compliance with regulatory requirements and driving the success of our medical device testing business.
About Us:
- BioTalent Search Private Limited is a leading recruitment agency specializing in life sciences and healthcare professionals.
Salary: ₹12,00,000 - ₹20,00,000 per annum (depending on experience)
About the Role:
This is an exciting opportunity for a seasoned Regulatory Affairs professional to lead our regulatory compliance efforts. Your primary responsibility will be to ensure that our medical devices meet all relevant regulatory standards, including CE Marking and FDA certification.
Your Key Responsibilities:
- Develop and implement robust Quality Control systems for scalable hardware manufacturing.
- 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.
Required Skills & Qualifications:
- 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.
- Proficiency in IEC 61326, IEC 61010, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards.
Benefits:
- A competitive salary package.
- Ongoing training and development opportunities.
- The chance to work with a dynamic and experienced team.
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