Job Description:
Regulatory Associate Role
You will be responsible for regulatory submissions worldwide, annual reporting to notified bodies and competent authorities, and maintaining compliance to standards and regulations.
The role requires a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.
* Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
* Assist in the implementation of MDSAP within the organisation.
* Support the team to obtain / retain country-specific regulatory registrations on a global basis.
Key Responsibilities:
1. Regulatory Compliance Enhancements
Maintain compliance with relevant medical device regulations, including EU MDR, US FDA, and ISO 13485.
2. MDSAP Implementation
Collaborate with the team to implement MDSAP (Medical Device Single Audit Program) within the organization.
3. Global Regulatory Registrations
Support the team in obtaining and retaining country-specific regulatory registrations globally.
4. Product Development and Submissions
Work closely with interdisciplinary team members to ensure product development meets regulatory requirements, and support submissions to regulatory bodies.
5. Post-Market Surveillance
Coordinate post-market surveillance activities, including customer complaints, adverse events, and product testing.
6. Regulatory Trend Monitoring
Monitor global regulatory trends and advise colleagues and external partners on compliance requirements.
Required Skills and Experience:
* Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Thorough understanding and knowledge of ISO 13485, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.