R&D Associate (Biotechnology & Medical Devices)

Company Description Cosma Health (formerly known as Femacare) is the world's first multi-prevention, non-hormonal therapeutics brand focused on women's health. Led by a team of doctors, the organization is dedicated to developing next-generation medical solutions that advance Women's Health 2.0. The company's work centers on innovative, science-driven products that address key health challenges for women in a safe and effective way. Cosma Health values collaboration with respected mentors and a dedicated internal team, creating an environment where professionals can contribute to impactful healthcare innovations.

We are hiring an R&D Associate to develop our biotechnology-based medical devices from concept to market. The role combines hands-on design, prototyping and testing with scientific communication, manufacturer sourcing, and support for CDSCO medical device registration and ISO 13485 quality documentation.

Research and product development Design, prototype and iterate biotechnology-based medical devices, including nanomaterial-based coatings, biosensors, diagnostics or biomaterials as relevant to our product.

Run bench testing and characterisation: material properties, biocompatibility (ISO 10993), sterility, shelf life, and performance verification. Move designs from prototype to pilot builds and support technology transfer, design verification and validation.

Maintain lab notebooks, SOPs and the design history file (DHF). Scientific communication Prepare and deliver presentations to leadership, partners, investors and at conferences. Draft research papers, posters, technical reports and patent support material. Track scientific literature and competitor products to inform the R&D roadmap.

Job Description:

Manufacturing and vendor management Identify, evaluate and audit contract manufacturers (CMOs) and component suppliers, preferably ISO 13485 certified. Coordinate trial batches, technical documentation and quality checks with vendors. Support costing, timelines and supplier agreements with the business team.

Regulatory Prepare documentation for CDSCO medical device registration, import or manufacturing licences and approvals under the Medical Device Rules, 2017, including device classification and the technical file.

Ensure work follows ISO 13485 quality management, ISO 14971 risk management and GLP; build the design controls and risk file. Liaise with regulatory consultants and respond to queries from authorities. Qualifications Required M.Sc. or M.Tech in Biotechnology, Biomedical Engineering, Biomaterials or a related field (pharma or biochemistry background acceptable).

2 to 5 years of hands-on R&D experience in a medical device, biotech or nanotech lab or company. Practical experience developing or testing medical devices, diagnostics or nanomaterial-based products. Working knowledge of CDSCO and the Medical Device Rules, 2017. Preferred Ph.D. or research experience in nanomedicine, biomaterials or diagnostics. At least one peer-reviewed publication, conference presentation or patent. Prior experience with CMOs, tech transfer, ISO 13485 manufacturing sites or CE/FDA submissions.