Systems and Regulatory Manager

CK Group are recruiting an a permanent basis for a Systems and Regulatory Manager to join a family-owned manufacturer and distributor of Medical Devices, predominantly to dental users, at their site based near Stevenage.

The Company:

Our clienthas an extensive history of manufacturing and distributing Medical Devices to dental users in the UK and markets globally.

Location:

This role is located close to Stevenage in Hertfordshire, close to the A1(M) so easily commutable by road.Systems and Regulatory Manager Role: this is a hands-on role in which you will lead a team in ensuring the continued compliance of the QARA systems, and in obtaining and maintaining all country specific regulatory clearances for Medical Devices tobe sold, ensuring compliance with individual country regulations.

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.
• Prepare for and lead 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 relatedchange requests.

Your Background:

The ideal candidate for this role will have/be:

• Educated to degree level or above in a relevant scientific or technical discipline with experience in a Senior RA/QA role in the medical device industry.
• Recent 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.

Entitlement to work in the UK is essential. For more information orto apply for this Systems and Regulatory Manager position, please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk. Please quote reference 52289.her at conferences or seminars appropriate to the discipline.

• Contribute to grant applications submitted by others.
• Begin to write, with appropriate support, bids for individual research funding or, where funders do not permit this, contribute to the writing of collective bids.
• Begin to referee papers for external bodies.
• Participate effectively in activities to achieve engagement with research, and/or impact beyond academia.
• Please note this list is not exhaustive, follow the link to view the full details

Criteria

Education, Experience & Achievements

Essential

• A relevant postgraduate research degree or equivalent professional experience in the field of carbohydrate material science.
• Previous experience of independent research.
• Presentations at conferences and a track record of publications in respected journals or equivalent in the field.

Desirable

• Research experience in polysaccharide and their industrial applications.
• Involvementin packaging material research and development.
• Materials formulation and characterisation expertise.

Skills & Knowledge

Essential

• Demonstrable communication skills in English language.
• Good IT skills in Microsoft/Adobe Programmes.
• Excellent report writing and presentation skills.
• Good time management and organisational skills.
• Good interpersonal skills. Initiative in planning research.
• Detailed subject knowledge in the area of research.
• Specialist knowledge and practical skills capable of leading to independent, original contributions to the subject area.
• High-level analytical skills.
• Full awareness of the ethical issues involved in their research work.

Desirable

• Project managementexperience.
• Team working skills.
• Communication skills.

Personal Attributes

Essential

• Ability to communicate complex information clearly, both orally and in writing.
• Ability to stimulate and encourage the commitment to learnin others.
• Ability to use initiative, and apply creativity, to solve problems that

Desirable

• A passion for making a positive impact on the environment especially in plastic waste.