Principal Regulatory Affairs Specialist
- 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.
Recommended Jobs
Registered Veterinary Technician (RVT)
Exciting Opportunity for a Registered Veterinary Technician (RVT) at Kemptville Animal Hospital! Are you an exceptionally organized and positive individual with a passion for providing top-notch ca…
House Sitter Wanted - Seeking Reliable House Sitter In Bakersfield, Ca $65/Hr
Hello there! I'm looking for a reliable and trustworthy house sitter to take care of my home in Bakersfield, California. The responsibilities include pet feeding, mail collection, plant care, and tras…
Line Cooks
Job Description Job Description Come work where you love to eat! Mary's Pizza Shack on 423 N McDowell Blvd in Petaluma are hiring Line Cooks. Apply online at Marys Pizza Shack is a fami…
Contremaître En CVC
Plan Group recherche un contrematre expriment en CVC pour travailler sur site Ottawa, en Ontario. Vous serez charg dinstaller, dentretenir et de rparer des systmes CVC dans le cadre de projets commerc…
LVN/RN Case Manager
Staff NurseLVN /RN Case Manager: Demonstrated competency in performance of professional nursing functions. Requires excellent oral and written communication skills. Ability to work with dying patie…
Travel Pharmacist | CA
Job Description Job Description Retail Pharmacist (Travel Pharmacist) Location : McKinleyville, CA Job Type : Full-time / Contract (Travel Pharmacist) Job Summary : As a Retail Pharmaci…
Senior ERP Functional SME (Payroll & Government Accounting)
Senior ERP Functional SME (Payroll & Government Accounting) Position Description We are seeking a highly experienced Senior ERP Functional Subject Matter Expert (SME) with a strong background in…
In-House Service Spec -2
Roles & Responsibilities Essential/critical functions: Follow necessary Customer Support protocols Interact with customers in a professional and enthusiastic manner via verbal and written co…
Unarmed Security Guard Commerce & Vernon
Job Description We are looking for a security officer for an entry-level position. The ideal candidate must be disciplined, and operate with complete integrity and respect. Must have manners, and be…
Discover Innovation in Healthcare at Palo Alto's Finest!
Registered Nurse - Pediatric Cardiovascular Operating Room - Travel - (Peds CVOR RN - Pedi CVOR RN) Join the vibrant city of Palo Alto as a Pediatric Cardiovascular Operating Room Nurse and immerse y…