Principal Regulatory Affairs Specialist

Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA.

As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.

Responsibilities

• 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.
• Develops global regulatory strategies for new and modified products.
• Prepares and submits PMA and IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications.
• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
• Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
• 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.

Required Qualifications

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for in vitro diagnostic devices and / or medical devices.
• 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).

Preferred Qualifications

• 5-7 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.
30+ days ago