-
Regulatory Affairs Supervisor
1 week ago
Real Staffing Ely, United KingdomOur client is an international medical device company passionate about improving lives around the world by accurately informing health decisions. Drawing on over 30 years' experience, they develop, manufacture and market pioneering diagnostic products. Theyuse advanced diagnostic ...
-
Regulatory Affairs Supervisor
6 days ago
Network Scientific Ltd. Ely, United Kingdom**Do you have experience in Med Device Regulatory Affairs? Are you looking for a new role with a global Diagnostics Company?** · An excellent opportunity has arisen for a Regulatory Affairs Supervisor to join the RA Team of a Diagnostics Company based close to Ely. This is an exc ...
-
Regulatory Affairs Supervisor
5 days ago
ProTech Recruitment Ltd Ely, United Kingdom**Regulatory Affairs Supervisor** · **Location: Cambridgeshire** · Are you looking for a new opportunity working for an established diagnostic company that develop, manufacture and market pioneering diagnostic products associated with food sensitivity and gut health. They are loo ...
-
Regulatory Affairs Supervisor
3 weeks ago
Omega Diagnostics Ltd Ely, Cambridgeshire, United Kingdom Full timeRegulatory Affairs Supervisor · Location: Littleport, Cambridgeshire - CB6 1SE · Salary: £45k + Benefits · Contract: Full time, Permanent · Hours: 37.5 pw · Benefits: · 25 days holiday a year plus bank holidays, increases with length of service · Company pension scheme, minimum 4 ...
-
Supervisory Health System Specialist
1 week ago
US Military Treatment Facilities under DHA Lakenheath, United Kingdom**Duties**: · - Plans, organizes, directs and manages the MTF Clinical Quality/Performance Improvement programs, ensuring compliance with legal and regulatory requirements · - Researches, interprets, analyzes and applies accrediting agency standards, as well as DoD, DHA and Air F ...
-
Corporate Tax Manager
2 weeks ago
AJ Chambers Peterborough, United Kingdom**Corporate Tax Manager** · **Peterborough** · **Up to £60,000 (DOE)** · **Is a friendly team with great benefits a role you have always wanted...** · **AJ Chambers are proud to have partnered with a top 20 firm of Chartered Accountants who are looking to appoint a Corporate Tax ...
-
Corporate Tax Manager
2 weeks ago
AJ Chambers Peterborough, United Kingdom**Corporate Tax Manager** · **Peterborough** · **Up to £60,000 (DOE)** · **Interested in joining a friendly team and receiving great benefits, then look no further.** · **AJ Chambers are proud to have partnered with a top 20 firm of Chartered Accountants who are looking to appoin ...
-
Shift Supervisor
1 week ago
Churchill's Sawston Sawston, United Kingdom**Shift Supervisor, Churchill's; Sawston** · **Part Time / Full time** · **£ £11.42 an hour** · As a Shift Supervisor, your responsibilities will mainly include preparing and cooking all menu items in line with the company's methods of production and procedure for quality control ...
-
Senior Quality Assurance Specialist, Business
2 weeks ago
STEMCELL Technologies Cambridge, United Kingdom**Job Description Summary**: · If you are a strong critical thinker looking to guide departmental policies, procedures, and processes, this Senior Quality Assurance Specialist could be the opportunity for you · By utilizing your scientific knowledge and quality background, your i ...
-
Supervisor (Permanent, Contract)
3 weeks ago
Omega Diagnostics Ltd Ely, Cambridgeshire, United Kingdom Full timeRegulatory Affairs Supervisor · Contract: Full time, Permanent · 25 days holiday a year plus bank holidays, increases with length of service · Company pension scheme, minimum 4% contribution · Private healthcare after successful completion of the probationary period · Enhanced Si ...
-
Ashesi University East of England, United KingdomAshesi's mission is to propel an African renaissance by educating ethical, entrepreneurial leaders. Located in Ghana, this private, non-profit university combines a rigorous multidisciplinary core with degree programs in Computer Science, Business Administration, Management Infor ...
-
Legal Aid Immigration Caseworker Supervisor
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomCompany Description · Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include c ...
-
Supervisor- 40 hours per week
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United Kingdom Full timeAlfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conveyancing, personal i ...
-
Immigration Caseworker
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomAlfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conveyancing, personal i ...
-
Legal Aid Immigration Caseworker Supervisor
5 days ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomJob Description · Company Description · Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our area ...
-
Legal Aid Immigration Caseworker Supervisor
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomCompany Description Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conv ...
-
Immigration Caseworker
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomCompany Description Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conv ...
-
Supervisor- 40 hours per week
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United Kingdom Full timeCompany Description Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conv ...
-
Legal Aid Housing Supervisor
2 weeks ago
Alfred James & Co Solicitors LLP Croydon, Cambridgeshire, United KingdomCompany Description Alfred James & Co Solicitors LLP is a small but experienced solicitor's office based in South Croydon. With a wide range of legal knowledge in various areas of law, we aim to provide friendly, professional, and reliable services. Our areas of work include conv ...
-
EPIP Peterborough, Cambridgeshire, United KingdomExecutive Affairs and Special Projects Officer (NEFA) · About the New England Foundation for the Arts: · The New England Foundation for the Arts (NEFA) is a 501(c)3 organization with an annual budget of $7.NEFA invests in artists and communities and fosters equitable access to t ...
Regulatory Affairs Supervisor - Ely, United Kingdom - Omega Diagnostics Ltd
2 weeks ago
Description
Regulatory Affairs Supervisor
Location: Littleport, Cambridgeshire - CB6 1SE
Salary: £45k + Benefits
Contract: Full time, Permanent
Hours: 37.5 pw
Benefits:
• 25 days holiday a year plus bank holidays, increases with length of service
• Company pension scheme, minimum 4% contribution
• Private healthcare after successful completion of the probationary period
• Death in service - 4x salary
• Enhanced Sick pay scheme
• Free fruit each day
• On-site Parking
• Company events
Overall Job Purpose:
To manage the Regulatory Affairs (RA) function in Omega Diagnostics to ensure it performs to a level that allows the organisation to meet all its regulatory responsibilities.
HR Coordinator - Job Purpose:
Regulatory Affairs Supervisor - Main Areas of Responsibility:
• Lead by example and demonstrate consistent, good HR practice and people management.
• Motivate the team to achieve potential through PDR's, regular 1:1's, and training or development. Manage day-to-day
Regulatory Affairs activities providing guidance and support to the Omega Diagnostics Regulatory Affairs team.
• Planning, coordination, and management of regulatory documentation activities.
• Review and compilation of Medical Device Files (such as Technical Files, DHF) for Omega Diagnostics products to
ensure adequate compliance with regulations.
• Preparation of documentation in support of regulatory function, i.e., post-market surveillance reports, risk
management plans/reports, and others, as required.
• Preparation of documentation in support of Omega Diagnostics regulatory submissions to comply with regulatory
authorities for registrations of products worldwide to gain marketing authorization.
• Notification to regulatory authorities, where applicable, of significant product changes to retain marketing
authorization.
• To liaise with partners and regulatory authorities to support regulatory submissions and vigilance activities.
• Review and approve product labelling, including instructions for use, container labels, packaging artwork, promotional
and training material for Omega Diagnostics products, as required.
• Review and approval of product development verification protocols and reports.
• Implementation and maintenance of a UDI system.
• Maintenance of Regulatory procedures to ensure continued compliance.
• Responsible for post-market surveillance activities.
• To ensure regulatory processes are followed and within required timeframes.
• Supporting internal and external audits to represent Regulatory Affairs positions and processes.
• Assess changes in regulations and determine their impact.
• Lead, mentor, and train team members as required.
• To be involved in ODL's areas of cGMP and continual improvement in all aspects of the QMS.
Regulatory Affairs Supervisor - Knowledge, Qualifications & Skills:
Essential:
• Knowledge of regulatory submission requirements for medical devices or IVDs in EU and MDSAP Countries (Canada, Brazil, Australia, USA)
• 5 year's experience in a regulatory position or professional qualification in Regulatory Affairs.
Desired:
• Supervisory experience
• Familiarity with IVD regulations
• Broader global regulatory requirements
Our core values:
• Customer Focus: customer satisfaction is not a department, everyone is responsible; listening to customers drives improvement
• Accountability: ask "what more can I do?"; takes ownership
• Collaboration: actively support your colleagues; be clear in communication; celebrate success and have fun together
• Respect: treat others as we would wish to be treated; respect the environment we work and live in
• Honesty: aspire to be open and transparent; take pride in building trust between ourselves and others
Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks, please assume that your application has been unsuccessful.
If you feel you have the necessary skills and experience to be successful in this role, click on "APPLY" today, forwarding an up-to-date copy of your CV together with a covering letter explaining how you meet the essential criteria.
No agencies please.
