Regulatory Affairs Expert
We are seeking a skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, managing day-to-day regulatory activities, and providing strategic regulatory insight to the team.
Key Responsibilities:
* Ensure the effectiveness of the Quality Management System (QMS) in accordance with regulatory standards
* Manage daily regulatory tasks and oversee multiple projects related to product enhancements and compliance
* Work closely with the QA Manager to prepare for notified body audits and other regulatory inspections
* Assist in the transition from MDD to MDR within the organisation
* Support the wider team to ensure that products meet the requirements of CE mark and FDA submissions
* Collaborate with suppliers to validate processes and maintain risk management files
* Provide strategic guidance on product development plans and ensure regulatory compliance
* Maintain awareness of global regulatory trends and advise colleagues and partners on compliance matters
* Monitor manufacturing and labelling changes for regulatory impact
* Keep abreast of changes in domestic and international regulations and guidelines
* Support the team with CE mark Submissions / Significant Changes and Notified Body interactions
* Prepare 510(k) regulatory filings and corresponding correspondence with the FDA
Requirements:
* Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company
* Regulatory certifications in MDR desirable
* A minimum of 4 years of experience in the medical device industry
* Thorough understanding of ISO 13485 and, ISO 14971, MDD & MDR
* Experience working directly with regulatory agencies
* Strong ability to manage critical projects as part of an interdisciplinary team
* Excellent problem solving and communication skills
* Self-motivated, highly organised, and detail-oriented
* Excellent oral and written communication skills
* Ability to work as part of a cross-functional team
Benefits:
This role offers a dynamic and entrepreneurial environment with opportunities for growth and development.
For Further Information:
Please contact James Cassidy for more information.