Job Title:
Regulatory Compliance Specialist
Job Description
The role of Regulatory Compliance Specialist is to support the organisation's regulatory activities and ensure compliance with global regulations.
* Support the implementation of MDSAP within the organisation, ensuring effective regulatory compliance.
* Collaborate with the Commercial Team and Distributors to ensure country-specific registration activities are understood and appropriately addressed.
* Work closely with interdisciplinary team members to maintain an effective Quality Management System (QMS) in accordance with regulations.
* Participate in internal and external audits, including notified body audits as required.
* Ensure product manufacture and testing meet the requirements for CE mark and FDA submissions.
* Maintain post-market surveillance activities, including customer complaints and adverse events logging, investigation coordination, and trend analysis.
* Monitor global regulatory trends and advise colleagues on compliance.
* Evaluate manufacturing and labelling changes for regulatory impact.
* Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
* Support the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.
Required Skills and Qualifications
This role requires a strong understanding of regulatory affairs, with expertise in MDSAP, CE mark, and FDA submissions. The ideal candidate will have excellent communication skills and be able to work effectively in a team environment.
Benefits
This position offers the opportunity to work with a dynamic team, contributing to the organisation's success in the regulatory affairs space.
Others
Candidates should have a passion for regulatory affairs and be eager to learn and grow in this field.