Regulatory Affairs Manager

Manager – Regulatory Affairs
Location: Electronic Co-operative Industrial Estate, Parvati Paytha, Pune
Job Type: Full-time (Work from Office)
Company: Serigen Mediproducts Pvt. Ltd.
About Serigen Mediproducts
Serigen Mediproducts is an innovation-driven, fast-growing biomedical devices company transforming the landscape of tissue regeneration. Founded as a spin-off from CSIR-National Chemical Laboratory, Serigen leverages pioneering silk-protein material technology to develop ground-breaking medical devices for tissue regeneration. Driven by patents across major global jurisdictions (India, US, EU, Japan) and backed by premier investors, we are executing an aggressive growth plan to make our products the global standard of care.
Key Responsibilities:
Global Strategy Development: Execute end-to-end regulatory strategy for innovative tissue regeneration products across Domestic (India) and Key International Markets (US FDA, EU MDR, APAC, etc.).
Dossier & Submissions Management: Prepare, review, and submit regulatory documentation required for global pre-market and post-market approvals.
Manage regulatory & Stakeholder Relations: Direct communications and build strong working relationships with regulatory agencies, auditors, clinical trial sites, external consultants, and key stakeholders.
QMS Compliance: Oversee internal and external ISO 13485 audits and mentor a team of regulatory specialists.
Intelligence & Advisory: Monitor global regulatory policy updates and provide strategic regulatory guidance to executive leadership.
Candidate’s Profile:
Education
Master’s or Ph.D. in Biological Sciences, Chemistry, Biotechnology, Biomedical Engineering, or a related scientific discipline.
Work Experience
Total Experience: Minimum of 2 years (ideally 3–5+ years) of dedicated experience in Regulatory Affairs and Quality Systems within the Medical Device or Biomaterials/Biomedical industry, specifically, in the areas listed below
Regulatory Submissions & Strategy:
Proven track record in compiling, reviewing, and submitting regulatory dossiers (Class II and Class III medical devices)
Practical exposure to international submission pathways such as US FDA (510(k) / PMA), EU MDR (2017/745), or CE marking is highly preferred.
Direct experience working with CDSCO (India) regulations and understanding of requirements of Medical Devices Rules - MDR 2017.
Quality Management Systems (QMS) & Audits:
Hands-on involvement in maintaining and improving ISO 13485 Quality Management Systems.
Demonstrated experience in handling notified body/regulatory agency external audits as well as internal QMS audits
Proven ability to collaborate with R&D, Manufacturing, and Commercial teams to extract technical documentation (DHF, Tech Files, Risk Assessments under ISO 14971 etc.).
Desired:
Experience in supporting or leading regulatory aspects of clinical investigations/trials, including reports writing, monitoring and seeking ethics committee permissions
Core Technical & Professional Skills
Generating Regulatory Intelligence by proactive approach in tracking the global regulatory shifts and compliance requirements.
Ability to liaison with Stakeholders like regulatory bodies, notified bodies, auditors, and clinical sites
Strong leadership and technical writing skills with ability to collaborate with Internal teams.
How to Apply:
If you are eager to shape the global regulatory footprint of a fast-growing biomedical leader, we encourage you to apply:
Complete the mandatory application form: https://forms.gle/ZSA9JFG6uCCBHF3B6
Email your updated CV to hr@serigenmed.com
(Note: Filling out the Google Form is mandatory for application screening)
Corporate Details
SERIGEN MEDIPRODUCTS PVT. LTD.
CIN: U74900PN2015PTC153912
Website: serigenmed.com
Address: Plot No. 39, Electronic Co-op Estate, Pune-Satara Road, Pune - 411009, India

Work arrangement
No