Denovo Bioinnovations is a deep-tech, R&D-driven; medical technology company developing next-generation surgical instruments and advanced robotic-assisted solutions to transform minimally invasive surgery.

We are looking for an experienced and driven regulatory professional to lead our Regulatory Affairs and Quality Assurance functions, driving regulatory compliance, quality systems and global market access as we move towards clinical validation and commercialisation.

Position: Lead – Regulatory Affairs & Quality AssuranceLocation: Pune, Maharashtra

Experience: 4-10 years

Employment Type: Full-time

Reporting To: Founder & CEO

Key Responsibilities1. Regulatory Affairs & Compliance

- Develop and execute regulatory strategies for medical devices across India and international markets.
- Lead CDSCO regulatory submissions, licensing and approvals, including applicable manufacturing and clinical investigation permissions.
- Manage regulatory pathways for medical devices under the Medical Devices Rules, 2017.
- Drive international regulatory submissions and market access strategies, including EU MDR (2017/745) and US FDA pathways (510(k), De Novo, as applicable).
- Prepare and review technical documentation, Device Master Files, Design Dossiers and regulatory submissions.
- Coordinate with regulatory authorities, notified bodies, testing laboratories and external consultants.

2. Quality Management Systems (QMS)

- Establish, implement and maintain the Quality Management System in accordance with ISO 13485.
- Lead internal audits, external audits, management reviews and certification activities.
- Develop and maintain SOPs, quality manuals, work instructions and quality records.
- Manage CAPA, non-conformances, change control, document control and supplier quality management.
- Ensure design control, design verification,



design validation and product lifecycle compliance.

3. Risk Management & Product Compliance

- Lead implementation of ISO 14971 risk management throughout the product lifecycle.
- Oversee product safety, risk-benefit analysis and regulatory compliance documentation.
- Coordinate biocompatibility, electrical safety, EMC, sterilisation and other applicable testing and validation activities.
- Ensure compliance with relevant medical device standards and regulatory requirements.

4. Clinical & Product Development Coordination

- Work closely with the Clinical Affairs and R&D; teams to ensure regulatory alignment during product development and clinical validation.
- Support clinical investigation applications and regulatory documentation.
- Ensure regulatory requirements are incorporated into product design, development and commercialisation plans.

5. Global Regulatory Strategy

- Develop regulatory roadmaps for India, Europe, the USA and other strategic markets.
- Evaluate applicable classification, conformity assessment and approval requirements for new product categories.
- Establish regulatory processes to support international expansion and future product launches.

Desired Candidate Profile
- Bachelor's or Master's degree in Biomedical Engineering, Biotechnology, Medical Technology, Pharmacy, Life Sciences or a related discipline.
- 4–10 years of relevant experience in Regulatory Affairs and Quality Assurance within the medical device industry.




- Strong working knowledge of CDSCO Medical Devices Rules, 2017 and ISO 13485.
- Experience with EU MDR 2017/745 and US FDA medical device regulatory frameworks.
- Hands-on experience in regulatory submissions, licensing, technical documentation and QMS implementation.
- ISO 13485 certified auditor
- Experience in ISO 13485 certification audits and regulatory inspections.
- Knowledge of ISO 14971, IEC 60601 series, ISO 10993 and applicable sterilisation standards.
- Prior experience with surgical instruments, electromechanical medical devices, laparoscopic instruments or robotic-assisted surgical systems will be an advantage.
- Solid leadership, stakeholder management, problem-solving and documentation skills.

What We Are Looking ForWe are looking for an independent regulatory leader who can take ownership of the company's regulatory and quality roadmap, establish robust compliance systems and work closely with engineering, clinical and manufacturing teams.

The ideal candidate should be capable of building and scaling the regulatory and quality function in a growing medical device company.

Why Join Denovo?

- Opportunity to work on creative, IP-backed surgical medical technologies.
- Direct involvement in the development and commercialisation of next-generation surgical devices.
- Opportunity to build and lead the Regulatory & Quality function.
- Work closely with surgeons, clinical institutions and multidisciplinary engineering teams.
- Be part of a high-growth deep-tech medtech startup with global ambitions.

- Interested candidates can share their updated CV at [email protected] with the subject line: "Application – Lead Regulatory Affairs & Quality Assurance". Join Denovo Bioinnovations and help shape the future of surgical technology.

📌 Lead – Regulatory & Quality Affairs (Pune)
🏢 Denovo Bioinnovations Private
📍 Pune