Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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.
Employment Type
Full-time
