Regulatory Affairs Specialist

Responsibilities:

• Responsible for the planning of regulatory activities. Develops and implements strategies with the goal of market access in identified geographies
• Acts as a core team member on development teams as Regulatory Affairs subject matter expert providing feedback and guidance throughout the product development lifecycle
• Plan, coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and other global regulatory agencies
• Negotiate and interact with regulatory authorities during the development and review process
• In collaboration with R&D maintain list of applicable standards
• Responsible for regulatory compliance and adherence with regulatory requirements
• Perform gap assessments and communicate standard/regulation changes and updates to staff and management as needed
• Coordinate with the clinical team on IDE supplements and/or amendments to update clinical investigational and protocol information as needed
• Evaluate proposed product changes and prepare ECO Regulatory Plans
• Provide regulatory support and guidance to clinical, R&D, operations departments, and project teams and staff as needed
• Interpret Company Policy
• Participate in internal and external audits as needed
• Mentor junior members of the Regulatory team

Authorities:

• Global regulatory reporting for company products
• Vigilance reporting
• Liaison with regulatory authorities as needed to resolve key regulatory issues

Requirements

Relevant degree

RAPS certification

Strong understanding of regulations, harmonized and recognized standards and guidance of medical devices

Strong understanding and knowledge of ISO 13485, 21 CFR 820, 93/42/EEC MDD and/or AIMD 90/385/EEC requirements / EU MDR 2017/745

Proven experience in regulatory submissions and registrations

At least 3 years of regulatory experience in medical device industry

At least 5 years of relevant CE, FDA and CMDR regulatory experience

Good level of knowledge and experience working with relevant standards such as ISO 14971, IEC 60601 series, ISO 10993

Experience and knowledge with the ETO sterilization process and the ISO 11737-1/11737-2 requirements.

Experience writing regulatory plan and strategies