Job Description
The role of Senior Regulatory Affairs Specialist – Post market will play a key part in the implementation of post-market activities. This is a fantastic opportunity for an experienced professional to add real value to the future success of our company.
Reporting to the Senior Regulatory Affairs Manager, the successful candidate will be responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions.
Key Responsibilities:
* Approval of Vigilance/MDR reporting as defined in each territory.
* Support and lead Regulatory Post Market System improvements.
* Participate in the implementation of Field Safety Corrective Action plan and associated activities if required.
* Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
* Provide RA Support to relevant Design Teams for Key Projects identified by us.
* Provide support to other RA Specialists in achieving success for the team.
* Manage and support trend data for regulatory reporting.
* Support Gap Assessment process and associated process improvements.
* Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to regulatory authorities.
Required Skills and Qualifications
* A degree level qualification in Engineering, Science, QA, or related field is essential.
* A minimum of five years experience at a senior regulatory level in the industry is essential.
* A minimum of five years' experience in the creation of regulatory submissions for premarket approval is required.
* Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
* Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.
Benefits
This role offers a highly competitive salary, bonus, pension, healthcare, and hybrid working environment. Our company culture is one of innovation, collaboration, and respect, providing opportunities for personal and professional development.
Others
This is an exciting opportunity for a seasoned professional to contribute to the success of our company. If you have the necessary skills and experience, we would love to hear from you.