Regulatory Affairs Associate, Class III Medical Devices

Job overview

The Regulatory Affairs Associate role is onsite in North Chicago, IL. Compensation is not specified. The associate supports regulatory submissions and government interactions for products requiring approval, with a focus on Class III implantable medical devices. The role prepares and manages submissions, reviews study protocols and reports, and assesses manufacturing changes against regulatory requirements. This work supports product approvals and changes that enable regulated products to reach patients.

What you'll do

• File applications and handle government interactions for product regulation
• author and submit PMA supplements, notices, reviews, and annual reports
• review and approve engineering and validation study protocols and reports
• review and approve manufacturing changes for Class III implantable devices
• prepare submissions and amendments
• analyze regulatory information
• manage agency meeting preparation and product change control.

What we're looking for

Skills & competencies

regulatory affairs associate

medical devices

class iii implantable devices

north chicago il

katalyst healthcares

pma supplements

fda regulations

regulatory submissions

engineering studies

validation studies

change control

product approvals

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related subject. The posting lists six years of pharmaceutical or industry-related experience and three to five years in quality systems or cross-functional project management.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.