Regulatory Affairs Specialist

Job Description:

The Regulatory Affairs Specialist is responsible for establishing and sustaining CE Technical files, and final review of deliverables for MDR regulatory compliance. Furthermore, this position will be responsible for gathering and establishing documentation relevant to international registrations and licenses and daily business needs. This includes, but is not limited to, MDSAP (US, Canada, Brazil, Australia, and Japan) and EU requirements.

• Provide Regulatory Affairs (RA) support for project remediation projects, process and systems remediations projects, and the preparation of regulatory submissions required to legally market medical devices in the European Union under MDR.
• Independently prepare and maintain EU MDR technical files, Australian and New Zealand registrations.
• Provide support for global product registrations and related regulatory affairs activities, as required.
• Appropriately execute project activities based on applicable products and systems designed to ensure that the product development process adheres to all regulatory requirements as well as objectives to the business.
• Represent the RA function on core teams. Provide RA guidance/opinions for team questions.
• Responsible for developing and executing regulatory strategies for sustaining and new products.
• Review and approve change orders for compliance with FDA, European and/or global regulations and standards.
• Create action plans to ensure milestones and due dates are met.
• Review Nonconformance Reports for regulatory impact under supervision.
• Support CAPA projects.
• Review and redline product labels/IFUs to meet global regulatory requirements.
• Ensure label conformity to global UDI requirements and submit/maintain UDI databases under supervision.
• Initiate and update regulatory requirements as required and per applicable SOPs.
• Participate in audits and inspections of the company and its Quality Systems.
• Prepare monthly reports on the status of current issues to the Manager of Regulatory Affairs.
• Request Certificate of Foreign Government and Certificates of Free Sale.
• Resolve regulatory issues and ensure companywide compliance.
• Perform special projects at the direction of the Regulatory Affairs Management.

Job Requirements:

• Bachelor’s degree from university in engineering or a scientific/technical field or Regulatory Affairs.
• Fluent in English.
• 2+ years in RA role within the Medical Device or Pharmaceutical industry.
• Available to travel for work.
• Ability to understand technical product information.
• Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision.
• Demonstrated organizational problem-solving skills, project coordination skills, and computer literacy in Microsoft Office suite, databases, and electronic document management systems.
• Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.
• Highly organized, detail-oriented mindset and ability to be flexible and multi-task in a dynamically changing environment.
• The ability to interpret and provide guidance on regulations from various countries.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.

Operating Company: Kerr