Regulatory Compliance Specialist in Borehamwood
Heather at CK Group is looking for a Regulatory Compliance Specialist to work with our client who are a global healthcare provider to hospitals, clinics and homes. The role will be based in Borehamwood, Hertfordshire for an initial period of 12 months.
The Company: Our client is one of the worlds leading healthcare providers and has been highly innovative in providing healthcare solutions to unmet medical needs through scientific advancement as well as strategic acquisitions and partnerships. They work at the critical intersection where innovations that save and sustain lives meet the physicians, nurses and pharmacists who make it happen. Our client is committed to improving outcomes for patients, and helping their partners meet the evolving challenges and opportunities in healthcare around the world.
The Location: Borehamwood is a town in southern Hertfordshire. It is a commuter town near St Albans and London, situated 12 miles from Charing Cross.
The main purpose of the role: This position is responsible for supporting the activities of the Design Owning Organisation (DOO). The successful candidate will work with the Product Design Owner (PDO) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced under the DOO.
Essential Duties and Responsibilities:
- Support the PDO in fulfilling requirements for regulatory compliance, design control and risk management activities for Orthobiologic products manufactured at Elstree.
- Lead activities required in the design and development assurance and documentation to maintain regulatory compliance, particularly for the new European Medical Device Regulation (MDR).
- Review and execute regulatory gap assessments against existing and new Regulation.
- Maintain and remediate Design History Files and Risk Management files for Elstree products.
- Generate and manage work flow for appropriate change control documentation.
- Project management of projects related to design assurance, risk management and DHF remediation.
- Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint investigations, change control, and regulatory submissions.
- Other tasks as needed.
- Solid communication skills - both written and oral.
- Organizational skills and attention to detail.
- Ability to work effectively independently and in team environment.
- Experience working in regulated industry (medical devices, drugs, biologics) is preferred.
- Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management is highly desirable.
Education and/or Experience: Bachelor's degree in a scientific or engineering discipline with 1-5 years' work experience or MS with 0-2 years' experience.
For more information or to apply for this position, please contact Heather on 0191 3848905 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45500 in all correspondence.