Regulatory Affairs Compliance Specialist
2 days ago
Meet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.
We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.
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.
- Bachelor's degree in Life Sciences, Engineering, or related field, or equivalent experience.
- At least 2 years of experience 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.
The estimated salary range for this position is $70,000 - $100,000 per year, depending on location and experience.
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