Principal Regulatory Affairs Specialist

REMOTE within the US

Careers That Change Lives

Actively contribute in the development of regulatory strategies for product development, approval, product lifecycle maintenance, and operational excellence activities. In this role, you will have the opportunity to support and mentor regulatory personnel, provide training as needed and lead activities for internal improvements.

PATIENT MONITORING (PM) offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our device solutions that improve clinical outcomes.
A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.


• Leads or compiles all materials required in submissions, license renewal and annual registrations.


• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.


• Monitors and improves tracking / control systems.


• Keeps abreast of regulatory procedures and changes.


• May direct interaction with regulatory agencies on defined matters.


• Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor's degree with 7+ years of experience in regulatory affairs and/or medical device industry OR Advanced degree with 5+ years of experience in regulatory affairs and/or medical device industry.

Nice to Have (Preferred Qualifications)