What are the responsibilities and job description for the Regulatory Affairs - Coordinator 3 position at Sunrise Systems, Inc.?
Only on W2 - No C2C
Contract Duration: 12 Months Contract
Location: Irvine, CA
- MUST HAVE review of manufacturing change requests
- Authored EU technical documentation
- Supported notify body change notifications in coordination with cross-functional teams
- Compiled and supported 510(K) activities, product lifecycle maintenance
Technical Skills
Must Have
- Ability to manage competing priorities in a fast-paced environment
- Attention to detail
- Good problem-solving, organizational, analytical and critical thinking skills
- Good written and verbal communication skills and interpersonal relationship skills
- Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)
Nice To Have
- Proficiency in document management systems and Microsoft Office
- Solid knowledge and understanding of global regulatory requirements for new products or product changes.
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Demonstrate a strong willingness to learn new processes, tools, and technologies.
- Follow guidance, ask questions, and training to develop role specific skills.
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
- Coursework, seminars, and/or other formal government and/or trade association training required
Job Description
- Hybrid 2-3 days in office.
- The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.S. Class II and EU Class II & Class III medical devices across the product lifecycle.
- This role prepares and maintains regulatory submissions and technical documentation, ensures ongoing compliance with FDA and EU MDR requirements, and serves as a regulatory partner to cross-functional teams.
- This role (Coordinator III) is hybrid (remote/in-office) and works with limited supervision.
Education
- Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field
Experience
- 5-7 years of Regulatory Affairs experience in the medical device industry
- Direct experience supporting Class II medical devices in the U.S. and Class II and/or Class III medical devices EU
- Hands‐on involvement with EU MDR technical files