Manager-Regulatory Affairs

About the Company - 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, Serigen is executing an aggressive growth plan to make its products the global standard of care.

Key Responsibilities

• Formulate, lead, and execute end-to-end regulatory strategy for innovative tissue regeneration products across domestic (India) and key international markets (US FDA, EU MDR, APAC, etc.).
• Prepare, review, and submit regulatory documentation required for global pre-market and post-market approvals.
• Direct communications and build strong working relationships with regulatory agencies, auditors, clinical trial sites, external consultants, and key stakeholders.
• Oversee internal and external ISO 13485 audits and mentor a team of regulatory specialists.
• Monitor global regulatory policy updates and provide strategic regulatory guidance to executive leadership.

Candidate Profile

Education

• Master's or Ph.D. in Biological Sciences, Chemistry, Biotechnology, Biomedical Engineering, or a related scientific discipline.

Work Experience

• Minimum 10 years of dedicated experience in Regulatory Affairs and Quality Systems within the Medical Device or Biomaterials/Biomedical industry.
• Proven track record in compiling, reviewing, and submitting regulatory dossiers for 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 Medical Devices Rules – MDR 2017.
• Hands-on involvement in maintaining and improving ISO 13485 Quality Management Systems; demonstrated experience handling notified body/regulatory agency external audits and 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.).
• Experience in supporting or leading regulatory aspects of clinical investigations/trials, including report writing, monitoring, and seeking ethics committee permissions is desirable.
• Strong regulatory intelligence capabilities, stakeholder liaison skills, leadership, and technical writing proficiency.

How to Apply

Interested candidates must complete the mandatory application form: https://forms.gle/ZSA9JFG6uCCBHF3B6 and email their updated CV to hr@serigenmed.com. Please note that filling out the Google Form is mandatory for application screening.

Our Company is an equal-opportunity employer and does not discriminate against any employee or applicant based on age, color, disability, gender, national origin, race, religion, sexual orientation or parental status.