The Regulatory Affairs Specialist will be primarily responsible for registrations and supporting the compilation and authoring of technical documentation to support regulatory submissions. This role also involves supporting the development of the quality management system (QMS) in accordance with relevant regulatory requirements for medical devices.
Responsibilities
- Lead regulatory compliance with internal and external regulatory requirements (FDA, ISO, EU-MDR, and individual country requirements).
- Coordinate regulatory training.
- Contribute to the development of an optimum QMS for business needs.
- Interpret ISO 13485, MDSAP, and MDR requirements.
- Assist in identifying actions required to ensure compliance with ISO 13485, MDSAP, and MDR.
- Provide inputs to project leads for project plans related to ISO 13485, MDSAP, and MDR.
- Conduct updates to labeling, SOPs, work instructions, trending tools, and policy documents.
- Support internal and external audits.
- Coordinate standards review activities.
- Oversee the development and/or modification of the Fourth Frontier QMS.
- Support management review and quality planning review forums.
- Assess and quantify requirements for QMS optimization.
- Drive GMP and GDP within the Quality organization.
- Identify and implement improvement opportunities for QMS efficiency and effectiveness.
- Develop and deliver training for QMS areas of expertise.
- Contribute to the development, maintenance, and improvements of policies and procedures.
- Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
- Liaise with notified bodies to manage certification changes.
- Ensure QMS reflects actual activities, business needs, and supports NPD requirements.
- Engage in relevant QMS IS discussions.
- Support internal and external quality system audits.
- Support IS change control assessment and approval.
Experience and Qualifications
- Minimum of 2 years’ experience in a regulated environment or equivalent preferred.
- Degree qualification in Science, Engineering, Business, or related discipline.
- Experience in a regulated environment and interaction with regulatory agencies.
- Some knowledge and understanding of US regulations (21 CFR Part 820) and ISO 13485.
- Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.).
- Experience in compliance risk situations.
- Computer literacy.
- Some travel may be required.
