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.
