Job Title: Regulatory Affairs Specialist

Location: Salt Lake City, UT, USA

Duration: 12 Months

Description:

Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require changes to device design.

Demonstrates working knowledge of healthcare-related regulations.

Demonstrates in-depth knowledge of US FDA guidance Deciding when to submit a 510k.

Applies relevant regulations and statutes to assess device changes for sustaining engineering projects.

Contributes to the strategic direction of regulatory pathway development.

Helps to ensure that the appropriate regulatory requirements are met for US, EU and OUS.

Applies knowledge and skills to a wide range of standard and non-standard situations.

Prefer a minimum of two years of regulatory experience evaluating device changes for US and EU regions.