Principal Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences

Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.

Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.

Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.

Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Reviews protocols and reports to support regulatory submissions.

Creates, reviews and approves engineering change requests.

Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.

Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

5 years' experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Ability to work effectively on project teams.

Must be able to manage multiple and competing priorities and manage programs with minimal oversight.

Strong written, verbal, presentation, and organizational skills.

Strong analytical and problem-solving skills.

Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.

Experience with medical device software requirements and software regulations.

Ability to identify risk areas and escalate issues as appropriate.