Regulatory Affairs Manager - United Kingdom
Division: Manufacturing (KeyMed)
As part of the Olympus global manufacturing community, Olympus KeyMed's Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology.
- Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
- Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
- Ensure current regulations and standards are available.
- Generate and maintain the DMR/DofC.
- Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
- Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
- Initial review of complaints to determine and record reportability.
- Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.
- Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.
- Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.
- Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.
- Participate in Continuous Improvement activities
- Undertake any assignment or duty as required by business needs.
- Adequacy and regular review of Technical File /Risk Management in accordance with current regulations.
- Maintenance of SOPs
- University degree in a scientific / engineering subject.
- At least five to ten years experience in a regulatory or quality role for a medical device manufacturer.
- Ability to perform ISO 9001 / 13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.
The interview will be competence based and the following competencies will be assessed:
- Customer Centricity
- Employee Focus
- Operational Excellence
- Social INvolvement
All applications must be received by the closing date of 26.03.2018 and will not be accepted after this deadline.
Should you have been referred to Olympus by a current employee, please email email@example.com to confirm the employees' name and the role you are applying for at the time of submitting your application.
You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006.
At Olympus, we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Olympus will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions.