ADAdecco India Private Limited
QA RA Senior Specialist
Bangalore ₹5-10 LPA Posted 20 Jun 2025
FULL TIME
Iso 13485
regulatory strategy
Job Description
- Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745).
- Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes.
- Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS).
- Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization.
- Experience interacting with the FDA and other regulatory authorities.
- Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.