Job Title: Regulatory Engineer / Regulatory Specialist
Location: Pittsburgh, PA / Bothell, WA / Remote (Travel to site as needed)
Industry : Regulatory, Medical devices (Must)
Experience Level Required : 2-3 years (RA Specialist), 3-7 years (Senior RA Specialist)
Job Summary:
We are seeking a Regulatory Engineer / Regulatory Specialist with experience in the medical device industry to support global regulatory activities, particularly across APAC and LATAM regions. The ideal candidate will have hands-on experience in product registration, regulatory submissions, compliance tracking, and regulatory intelligence management.
Job Description :
Product Registration Support- APAC, LATAM as per the assigned countries
Prepare and review the documentation required for Renewal/Change submission/Notification/Re-registration of Medical devices
Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs
Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information.
Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
Maintains information systems (electronic and paper) for regulatory information and reports.
Oversee and ensure maintenance of regulatory licenses renewals on timely manner
Clearly conveys information to peers, supervisors and other stakeholders
Supports the development of internal RA systems and procedures.