Principal Regulatory Affairs Specialist

Overview

Position Summary:

Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies.  Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion.  Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.

Responsibilities

Key Accountabilities

Essential Functions:

• Participates as the regulatory design team member for new and significant changes to IL-labeled product, providing early input on analytical and clinical test requirements, acceptance criteria and regulatory submission strategy.
• Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan.
• Performs labeling reviews and Change Order (CO) reviews/signatures for new product and significant product modifications.
• Prepares FDA 510(k), Health Canada license and EU Notified Body submissions for new products and significant modifications, coordinating deliverables with R&D and Marketing, authoring summary analytical and clinical reports, interfacing with Regulatory agency/Notified Body and advising on strategies and requirements throughout the registration process.
• Reviews and approves commercial materials for compliance/consistency with registrations, including by not limited to brochures, presentations and training materials.
• Other regulatory activities as needed to support new product launches and significant product modifications.

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs.

Skills & Capabilities:

• Effective verbal communication in individual and group settings
• Strong writing skills for submission preparation
• Detail oriented with good organizational skills and able to meet deadlines
• Ability to prioritize while balancing multiple projects, with strong planning skills
• Effective decision maker

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Requires a Bachelor degree, preferably in regulatory or science related areas
• Minimum of 8-years’ regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
• Experience in the preparation of regulatory submissions to US FDA, Health Canada and/or EU Notified Body with in the past 8 years.
• Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulatory, MDSAP Companion Document, with some exposure to either EU MDR or EU IVDR
• Effective verbal and written communication in individual and group settings
• Ability to prioritize and balance work load, with minimal supervision and in a fast pace environment
• Language fluency: English essential

International Mobility:

• Required: No

Travel requirements:

• 5-10% of time per year, domestic and international