Published11 May 2023
LocationHitchin, England, United Kingdom
Schottlander is a family-owned manufacturer and distributor of Medical Devices, predominantly to dental users. We are recruiting on a permanent basis for an Operations and Regulatory Manager to join us and to coordinate and oversee our organization’s functions, improve the efficiency and resilience of our operations, and help ensure our ongoing compliance to relevant regulations.
Schottlander has a 100-year history of manufacturing and distributing Medical Devices to dental users in the UK and markets globally. Following a period of investment in R&D, we are recruiting to strengthen our management team, to help create the systems that will support our anticipated growth.
This role is predominantly office based and located close to Stevenage in Hertfordshire, close to the A1(M) so easily commutable by road.
Operations and Regulatory Manager Role:
This is a hands-on role in which you support the key functions of the business by leading a team to ensure:
- the continued compliance of the QARA systems
- obtaining and maintaining all country specific regulatory clearances for Medical Devices to be sold, ensuring compliance with individual country regulations.
- manage our contracts with external IT and communication suppliers
- oversee the management of our warehouse operations
- contract with and manage our relationships with the delivery services used to supply UK customers
- support and enhance the compliance, efficiency, customer satisfaction and profitability across our business
Your main duties will be to:
- Manage and lead colleagues currently responsible for QARA activities, including a Medical Devices Specialist, and form a new Systems and Regulatory Department, managing this department’s schedule and budget.
- Manage Preparation for all Notified Body audits, including ISO13485, ISO9001, EU MDR and manage internal auditing to ISO13485.
- Maintain and/or establish regulatory specific device market approval records, including MDSAP/ISO13485/EU MDR and maintain regulatory certifications for existing product lines.
- Ensure notified changes and change controls are submitted to Notified Bodies (NB’s).
- Ensure compliance of all regulatory artwork, user instructions and regulatory markings, including managing changes to IFUs, labels and packaging.
- Complete the transition of the complaints system to new software system (Q-Pulse), which will also cover certification, labelling, and related change requests.
- Negotiate and manage contracts with our key communications and IT suppliers and our delivery service providers.
- Oversee our warehouse operations to increase efficiency and customer satisfaction.
The ideal candidate for this role will have/be:
- Educated to degree level or above in a relevant scientific or technical discipline, or in Business, Operations Management or related field.
- Experience in an Operations Manager role or a Senior RA/QA role in the medical device industry.
- Recent management experience and knowledge of ISO13485/MDSAP/MDD/EU MDR, including leading successful certification and/or recertification audits as well as a proven record of success in both developing regulatory processes and developing the team members to work within and manage these processes.
- A clear understanding of CE Mark and Technical File Compilation.
- Experience of Class I and Class II medical devices would be an advantage.
Compensation for a successful candidate would start at £65,000 per annum plus on-target bonus and participation on company profit related pay scheme (average of over 10% of base salary over last 5 years). Package also includes pension, life insurance and private healthcare.
It is essential that applicants hold entitlement to work in the UK
Job Types: Full-time, Permanent
Salary: From £65,000.00 per year
- Company pension
- Life insurance
- Private medical insurance
- Monday to Friday
Supplemental pay types:
- Bonus scheme
- United Kingdom (required)
Work Location: In person