Medical Device Compliance Manager
3 months ago
As a Medical Device Compliance Manager, you will play a critical role in maintaining and enhancing the compliance standards for our medical devices, with a particular focus on software, in accordance with MDR, FDA, and DCB requirements. You will be responsible for reviewing, assessing, and resolving (issues relate to) our device manufacture and implementation strategies. The oversight of the compliance aspects of product development, regulatory submissions, and quality management systems are managed by a central compliance program, and this role is a key stakeholder for that central program.
This role will be office based in Windsor 5 days per week for the first 3 months and then revert to a hybrid model of 3 days office based in Windsor per week.
Role Responsibilities
- Develop and implement compliance strategies and policies related to medical devices, with a strong focus classification and risk diligence (ISO and DCB ).
- Ensure that all medical devices (including products that can be marketed as medical device) are assessed for relevant regulatory compliance.
- Collaborate with cross-functional teams to integrate compliance considerations into product design and development processes.
- Manage and coordinate regulatory submissions and approvals for medical devices.
- Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards.
- Provide guidance and training to team members on compliance matters.
- Stay up-to-date with evolving regulations and industry trends related to medical device compliance.
- Liaise with regulatory agencies and notified bodies as necessary.
Required Skills and Experience
- Bachelor's degree in a relevant field (e.g., Bio-engineering, Life Sciences, Regulation). Masters, preferred.
- Minimum of 5 years of experience in medical device compliance, with expertise in software compliance.
- Strong knowledge of relevant regulations, standards, and guidelines.
- Excellent communication and research skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Detail-oriented with a strong commitment to quality and compliance.
- Prior experience interacting with regulatory agencies and notified bodies.
As an equal opportunities employer, InterSystems does not condone discrimination on the basis of age, disability, sex, sexual orientation, pregnancy and maternity, race or ethnicity, religion or belief, gender identity, or marriage and civil partnership.
We aspire to have a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply and join our organisation.
-
Medical Device Compliance Specialist
7 hours ago
Windsor, Windsor and Maidenhead, United Kingdom InterSystems Full timeJob SummaryWe are seeking a highly skilled Medical Device Compliance Manager to join our team at InterSystems. As a key member of our global compliance team, you will play a critical role in maintaining and enhancing our compliance approach to ensure all our products and processes comply with regulatory requirements, standards, and guidelines related to...
-
Medical Affairs Advisor
3 months ago
Windsor, United Kingdom Bial Full time**The Position** Reporting to the Director, Medical Affairs - UK & ROI, the Medical Affairs Advisor will work cross-functionally to support the development and execution of BIAL’s medical strategy and tactics, and ensure they reflect the needs of the UK market aligned to the brand strategy in line with the medical budget. **Duties and...
-
Software QA Engineer
2 months ago
Windsor, United Kingdom NetApp Full timeTitle: Software QA Engineer (BIOS, IDrac)) Location: Bangalore, Karnataka, IN, 560071 Requisition ID: 126339 Job SummaryAs a Software Engineer of the Platform software validation team, you will work as part of the team responsible for software validation, testing and automation of Platform software and hardware. As part of the Research and Development...
-
Medical Receptionist
3 months ago
Windsor and Maidenhead, United Kingdom SHR Full timeJob Opportunity: Experienced Medical Receptionist Location: GP Surgery in the Borough of Windsor Days and Hours: - Mondays: 08:00 - 18:30 - Tuesdays: 08:00 - 18:30 - Wednesdays: 13:00 - 18:30 - Thursdays: 13:00 - 18:30 - Fridays: 13:00 - 18:30 Start Date: Last week of August (preferred) Contract Duration: 1 Month Computer System: EMIS Web Required...
-
Front Desk Receptionist
2 months ago
Windsor, United Kingdom Clarence Medical Centre Full time**PLEASE ONLY APPLY IF YOU CAN DO THE DAYS AND HOURS STATED** We are looking for a receptionist to work across both of our medical centres - one in Windsor (main site) and one in Egham (branch site). Hours and days are shown below - _**PLEASE ONLY APPLY IF YOU CAN DO BOTH THE STATED HOURS AND DAYS AS SHOWN.**_ - **Monday** 0830 to 1730 - branch site Egham -...
-
Senior Compliance and Policy Specialist
2 months ago
Windsor, United Kingdom Centrica Full timeWe are Centrica! We’re so much more than an energy company. We’re a family of brands revolutionising a cleaner, greener future. Working here is **#MoreThanACareer** - we’re powered by purpose. Together we can make an impact that will truly change tomorrow. Whether you’re developing cutting-edge green tech, helping customers on the front line or...
-
Customer Service Advisor
1 day ago
Windsor, United Kingdom CSI Leasing Europe Full timeFreedom Tech is a subsidiary of CSI leasing Europe. We are primarily an Asset Finance company and offer innovative financing solutions for all technology purchases to schools and businesses.We are currently looking for someone to join our Tech 4 Learners team in Windsor as a ‘T4L Parent Support – Customer service advisor’, primarily working with...
-
Customer Service Advisor
7 hours ago
Windsor, United Kingdom CSI Leasing Europe Full timeFreedom Tech is a subsidiary of CSI leasing Europe. We are primarily an Asset Finance company and offer innovative financing solutions for all technology purchases to schools and businesses.We are currently looking for someone to join our Tech 4 Learners team in Windsor as a ‘T4L Parent Support – Customer service advisor’, primarily working with...
-
Customer Service Advisor
20 hours ago
Windsor, United Kingdom CSI Leasing Europe Full timeFreedom Tech is a subsidiary of CSI leasing Europe. We are primarily an Asset Finance company and offer innovative financing solutions for all technology purchases to schools and businesses.We are currently looking for someone to join our Tech 4 Learners team in Windsor as a ‘T4L Parent Support – Customer service advisor’, primarily working with...
-
HR, Payroll
2 months ago
Windsor, United Kingdom Ogilvie Davies Ltd Full time**Main responsibilities**: HUMAN RESOURCES - Maintain accurate employee records in personnel files - Help and assist Managers with general queries and escalate to Senior Management when appropriate - Process new starter and leaver documentation - Update internal databases (e.g., absences) PAYROLL - Process the company’s payroll every pay period - Create...
-
Manager, Affiliate PV Coordination
8 hours ago
Windsor, United Kingdom Parkside Office Professional Full timeGood knowledge of PV related regulationsActs as a subject matter expert for APVCHybrid My client is seeking a Manager, Affiliate PV Coordination.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU...
-
Manager, Affiliate PV Coordinator
3 days ago
Windsor, United Kingdom Parkside Office Professional Full timeGood knowledge of PV related regulationsActs as a subject matter expert for APVCHybrid My client is seeking a Manager, Affiliate PV Coordinator to their Global team.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as...
-
Manager, Affiliate PV Coordination
2 weeks ago
Windsor, United Kingdom Parkside Recruitment Full timeMy client is seeking a Manager, Affiliate PV Coordination.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to...
-
Manager, Affiliate PV Coordination
3 weeks ago
Windsor, United Kingdom Parkside Recruitment Full timeMy client is seeking a Manager, Affiliate PV Coordination.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to...
-
Manager, Affiliate PV Coordination
3 weeks ago
Windsor, United Kingdom Parkside Recruitment Full timeMy client is seeking a Manager, Affiliate PV Coordination.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to...
-
Manager, Affiliate PV Coordination
1 week ago
Windsor, United Kingdom Parkside Recruitment Full timeMy client is seeking a Manager, Affiliate PV Coordination.The post holder will be responsible for the maintenance and creation of departmental procedures including, but not limited to, Standard Operating Procedures (SOPs, as applicable) as well as ensuring that the EU affiliates are supported in the performance of pharmacovigilance activities according to...
-
Graduate Internship in Technical Services
2 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom InterSystems Full timeInterSystems UKI Graduate Internship OpportunityInterSystems UKI is pleased to announce an opportunity for a Graduate Intern to become part of their knowledgeable Technical Services team. This paid internship provides a distinctive opportunity to enhance your skills and develop professionally within a dynamic global software organization.Location: Windsor,...
-
Customer Training Support Advisor
2 hours ago
Windsor, Berkshire, United Kingdom CSI Leasing Europe Full timeFreedom Tech is a subsidiary of CSI leasing Europe. We are primarily an Asset Finance company and offer innovative financing solutions for all technology purchases to schools and businesses. We are currently looking for someone to join our Tech 4 Learners team in Windsor as a ‘T4L Parent Support – Customer service advisor’, primarily working with...
-
Customer Solutions Manager
3 months ago
Windsor, United Kingdom Trilliant Full timeCustomer Solutions Manager Trilliant offers a universal communications platform that is at the convergence of the smart grid, smart city, and global Industrial Internet of Things (IIoT) applications. We bring together multi-technology solutions, global capabilities, and mission-critical communications to deliver future-proof solutions. We are a...
-
Senior Manager Internal Audit
3 months ago
Windsor, United Kingdom Liberty Global Full timeWe’re looking for an Senior Manager, Internal Audit to join our team in London. The Audit, Risk & Compliance Senior Manager is responsible for leading and developing the team to deliver the Company’s Internal Audit, Compliance & Ethics and Risk Management programs. This includes co-ordination with Risk and Compliance from local operations to ensure a...