*Must be located on the East Coast*
*W-2 candidates only*
Position Summary:
The Operations Specialist, Regulatory Affairs, will support the regulatory process by managing KPIs, generating reports, and collaborating cross-functionally to ensure compliance with global regulatory requirements. This role provides process support rather than handling regulatory submissions and requires strong communication and reporting skills.
Responsibilities:
- Collaborate with regulatory teams (US, Canada, EMEA, APAC, LatAM) and cross-functional stakeholders to implement regulatory policies, processes, and reporting tools in alignment with business goals.
- Support new product development, ensuring compliance with global regulatory standards.
- Facilitate timely review and approval of product changes (e.g., ECO/DCOs) for regulatory compliance.
- Keep up-to-date with global regulations and standards, providing regular updates and impact assessments.
- Work with Marketing, R&D, and other teams to ensure compliant product labeling and promotional materials.
- Maintain regulatory records and files.
- Perform other duties to support the regulatory function.
Requirements:
- B.S./B.A. in Life Sciences, Engineering, or related field, or equivalent experience.
- 2+ years in Medical Device Regulatory Affairs.
- Familiarity with US FDA 21 CFR 820, EU MDR 2017/745, and IMDRF/GHTF.
- Proficiency in Microsoft Office, strong written and verbal communication, project management, and organizational skills.
