A fantastic opportunity for an experienced Medical Device Regulatory Compliance Manager to lead a Team in a state of the art manufacturing site.
- Healthcare cover
- Provate Medical
- Life Assurance
- 25 Days Holiday
- Bespoke training/development opportunities
Within the Regulatory Compliance Manager role, you will oversee and improve Regulatory Compliance related processes, including Change Management, Customer Complaints, Risk Management & Document Control. You will provide oversight of all other sites within the business as part of the companies role as legal manufacturer.
You will manage a team of 3 as well as manage second and third-party audits, including responding to related findings and actions and assume some of the responsibilities of the Person Responsible for Regulatory Compliance, specifically responsibility for the sub clause(s) of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745
- Manage the Regulatory Compliance team, while interfacing with the Quality Systems and QA teams supporting manufacturing and packaging & labelling operations.
- Oversee the change management process, including liaising with Global & Regional RA/QA teams to complete regulatory impact assessments.
- Be the liaison person with Notified Bodies and other regulatory bodies
- Plan and coordinate Notified and Regulatory Body audits.
- Oversee all aspects of the Legal Manufacturer within the company
- Supports third party audits, including Customer & Virtual Manufacturer audits.
- Manage actions and responses to be taken in relation to regulatory and third party audits.
- Manage changes and improvements to the quality system to ensure that all facilities remain compliant with applicable current and future standards and regulations.
- Provide support to design transfer activities as required.
- Direct the Management Review process, and participation as required in other facility, regional and business management reviews as required.
- Leads continuous improvement activities associated with Regulatory Compliance processes.
- 2-5 years' experience within Quality Assurance area.
- Experience with People Leadership.
- Knowledge of and experience of regulations for medical devices, including and not limited to; ISO Standards, MDD, MDR, MDSAP.
- Internal Audit experience and dealt with external auditors.
- Excellent written and verbal communication skills.
- Excellent organisational skills.
- Competent in basic statistical methods (R&R, SPC, 6Sigma)
- Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and knowledge of relational database systems.
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.