Senior Regulatory Affairs (RA) Specialist
On-siteBengaluru, Karnataka, India
Job Summary
Develop and execute global regulatory strategies for medical devices and combination products. Prepare, compile, and maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR Technical Documentation, and international registration dossiers. Perform regulatory impact assessments for design changes, manufacturing updates, software revisions, and labeling modifications. Support product lifecycle management by maintaining compliance and global market registrations while collaborating with R&D, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, and Marketing teams. Prepare documentation for internal and external audits and ensure adherence to evolving regulatory requirements and standards such as ISO 13485 and ISO 14971.
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related discipline
- 5+ years of experience in Regulatory Affairs within the medical device or combination product industry
- Experience preparing regulatory submissions and technical documentation for global markets
- Working knowledge of FDA regulations, EU MDR requirements, and international medical device regulations
- Experience with regulatory change assessments, product registrations, and lifecycle management activities
- Strong understanding of medical device regulatory requirements and submission processes
- Knowledge of standards including ISO 13485, ISO 14971, IEC 60601-1, ISO 20417, and ISO 15223-1
- Strong technical writing, documentation review, and analytical skills
- Ability to manage multiple regulatory activities and meet timelines
- Strong collaboration and communication skills with cross-functional teams
- Attention to detail with strong compliance mindset
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