Job Title: Regulatory Compliance Expert
We are seeking a highly skilled and experienced Regulatory Compliance Expert to join our organisation. The successful candidate will report to the Senior Regulatory Manager and be responsible for ensuring compliance with regulatory standards, managing submissions, and maintaining relationships with notified bodies and FDA.
This role requires a strong working knowledge of medical device regulatory requirements and standard practices in the industry. The ideal candidate will be an enthusiastic self-starter with excellent organisational skills, able to balance immediate vs. long-term priorities and manage multiple tasks effectively.
Key Responsibilities:
* Work closely with the QA Manager to ensure the effectiveness of the Quality Management System (QMS) in meeting regulatory requirements
* Manage day-to-day regulatory activities, including product and compliance enhancements
* Support notified body audits and other audits as required
* Assist in the migration from MDD to MDR within the organisation
* Collaborate with the wider team to ensure product manufacture and testing meets CE mark and FDA submission requirements
* Work with suppliers to ensure process validations and risk management files meet regulatory standards
* Provide strategic regulatory insight to team members regarding product development plans
* Coordinate country-specific registration activities with the Commercial Team and Distributors
* Maintain Post Market Surveillance activities, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to improve products
* Evaluate manufacturing and labelling changes, promotional materials, and assess their regulatory impact
* Stay up-to-date with global regulatory trends and requirements, advising colleagues and external partners on compliance
* Carry out other regulatory-related duties as required
Requirements:
* Bachelor's degree in engineering or science with at least 4 years of experience in a medical device company
* Regulatory certifications in MDR desirable
* Minimum 4 years of experience in the medical device industry
* Thorough understanding of ISO 13485 and ISO 14971, MDD & MDR
* Proven track record in project management and ability to meet deadlines
* Experience working directly with regulatory agencies
* Strong problem-solving and communication skills
* Self-motivated, highly organised, and detail-oriented
* Excellent oral and written communication skills
* Able to work as part of a cross-functional team