Job Overview
We are seeking a detail-oriented and dedicated Medical Device Compliance Specialist to join our team. This role is integral to ensuring that our medical devices meet all regulatory standards and quality assurance requirements. The successful candidate will play a vital part in maintaining compliance across all stages of product development, manufacturing, and post-market surveillance. This position offers an excellent opportunity for professionals passionate about healthcare quality and regulatory affairs to contribute to innovative medical solutions.
Duties
- Develop, implement, and maintain compliance procedures aligned with relevant regulations such as ISO 13485, MDR, and FDA standards.
- Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality assurance protocols.
- Review technical documentation, including design dossiers, risk management files, and validation reports, to verify compliance.
- Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance to address compliance issues proactively.
- Monitor changes in regulatory requirements and update internal policies accordingly.
- Assist with the preparation of documentation for regulatory submissions and inspections.
- Provide training and guidance to staff on compliance standards and quality assurance practices.
Experience
- Proven experience in medical device regulation, quality assurance, or compliance roles within the healthcare industry.
- Strong understanding of ISO 13485 standards and European Medical Device Regulation (MDR) or FDA regulations.
- Experience conducting internal audits and managing corrective actions effectively.
- Excellent organisational skills with the ability to manage multiple projects simultaneously.
- Strong analytical skills with attention to detail in reviewing technical documentation.
- Prior experience working collaboratively across departments to ensure compliance objectives are met.
This role is ideal for professionals committed to maintaining the highest standards of safety and quality in medical device manufacturing while supporting innovative healthcare solutions.
Pay: £4,853.00-£6,250.00 per month
Benefits:
- Casual dress
- Discounted or free food
- Health & wellbeing programme
Work Location: In person
