Job Title: Regulatory Compliance Professional
The Regulatory Compliance Professional will ensure the company's products and services adhere to relevant regulations and standards. They will collaborate with cross-functional teams to facilitate regulatory approval, manage submissions, and maintain compliance with evolving requirements.
1. Develop and execute regulatory strategies for product registration, approval, and compliance ensuring adherence to global regulations.
2. Manage daily regulatory activities and oversee multiple projects related to regulatory compliance enhancements.
3. Oversee the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
4. Support the team in obtaining and retaining country-specific regulatory registrations on a global basis.
5. Implement the Medical Device Single Audit Program (MDSAP) within the organisation.
6. Ensure compliance with national and international regulatory requirements and quality standards.
7. Identify and assess potential regulatory risks proposing effective mitigation strategies.
8. Collaborate with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into Quality Management Systems and product development processes.
9. Stay current with changing regulations, guidelines, and industry trends.
10. Contribute to maintaining the highest level of quality by assessing overall risk profiles and creating programs/tools to mitigate potential risk.
11. Maintain Post Market Surveillance activities including but not limited to:
* Working collaboratively with manufacturers.
* Logging customer complaints and adverse events.
* Coordinating investigations between complainants and contract manufacturing sites and addressing initiatives to test, change and improve the products as required.
* Regulatory trending and reporting activities as required.
12. Manage CE mark submissions, significant change notifications, and Notified Body interactions.
13. Support the team with the preparation of international regulatory filing, including 510(k) submissions and subsequent FDA correspondence.
14. Review/approve public-facing materials for regulatory compliance.
15. Carry out other regulatory-related duties as required.