Manager, Regulatory Affairs (Medical Devices & Drug Device Combination Products)
1 month ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Cambridge | Full-Time
Contract Type: Permanent
Closing Date
Reference: VN1898
Your mobile application
You may find making an application much easier from a desktop computer. So why not forward yourself a link to this vacancy to pick up and apply on a desktop or laptop later. Alternatively you can send the link to someone you think would be suitable for the role.
Send link Apply anyway
Apply now
Vectura Group is a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). Our focus is on delivering cutting-edge solutions that improve patient outcomes. We are seeking a skilled and motivated Regulatory Affairs Manager to join our team and help drive the success of our medical device and DDCP regulatory activities.
Key Responsibilities
As a Regulatory Affairs Manager at Vectura, you will play a key role in ensuring the regulatory success of our medical devices and DDCPs. Your responsibilities will include:
Regulatory Leadership
Assume the role of Regulatory Affairs Manager with specialized expertise in medical devices and DDCPs. Lead regulatory activities across the Vectura Group to support product approvals and ensure alignment with corporate goals.
Submission & Compliance
Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with the Medical Device Directive (MDD) and Medical Device Regulations (MDR). Author and maintain MDR Technical Files, Design Dossiers, and ensure devices comply with national and international regulatory requirements.
Cross-Functional Collaboration
Collaborate effectively with teams in regulatory, quality assurance, and device engineering to ensure seamless regulatory support and compliance throughout product development and commercialization.
Product Development Support
Provide regulatory guidance for new product evaluations and ongoing device development activities, including risk management, human factors, biocompatibility, and clinical evaluations. Assist in the creation of Instructions for Use (IFU) and labels.
Regulatory Intelligence
Stay up to date on global regulatory changes, new ISO standards, ICH guidelines, FDA regulations, and other guidance. Conduct impact assessments and ensure the business adapts to evolving regulatory landscapes.
Regulatory Documentation
Prepare and submit regulatory documentation, including communication with regulatory authorities and notified bodies. Ensure successful collaboration for Notified Body opinions and submissions related to DDCPs and drug-device constituent parts.
Technical Documentation & Maintenance
Maintain and archive technical documentation and regulatory files, including the regular review and updates required to ensure ongoing compliance with current standards and legal requirements.
Change Impact Assessments
Perform impact assessments on planned changes to medical devices, documenting regulatory impacts through assessment checklists and overseeing any necessary updates to regulatory files.
Project Leadership
Lead and support strategic regulatory projects such as the implementation of EUDAMED, UKCA marking, Quality System Management Reviews (QSMR), and the development of new devices.
Clinical & Commercial Strategy
Contribute to the regulatory strategy for clinical trial and commercial activities, ensuring alignment with local legislation, language requirements, and registration protocols.
Verification & Validation Support
Assist in the planning, implementation, and documentation of verification and validation activities for device development projects.
Regulatory Newsletter & Intelligence
Contribute to Vectura's Regulatory Newsletter and provide insights on relevant regulatory updates.
Leadership Support
Provide support to the Head of Regulatory Affairs and senior management on key initiatives related to medical devices and regulatory compliance.
Qualifications & Experience
Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products (DDCPs).
In-depth knowledge of MDD, MDR, ISO standards, FDA regulations, and other relevant global regulatory frameworks.
Experience authoring MDR Technical Files, Design Dossiers, and other regulatory submissions.
Strong understanding of regulatory submissions, including interaction with regulatory authorities and notified bodies.
Excellent cross-functional collaboration skills with teams in regulatory, quality, and engineering.
Project management experience in regulatory projects such as EUDAMED or UKCA.
Strong attention to detail, problem-solving, and regulatory intelligence capabilities.
Why Vectura?
At Vectura, you'll join a team of innovators working at the forefront of medical technology, where your contributions will directly impact patient care. We offer a dynamic work environment, opportunities for professional development, and a collaborative culture dedicated to achieving excellence.
How To Apply
Join us at Vectura Group and help shape the future of medical devices and combination therapies!
LNKD1_UKTJ
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Legal
* Industries
Operations Consulting
Referrals increase your chances of interviewing at The Law Offices of James A. Flexer by 2x
Get notified about new Regulatory Affairs Manager jobs in Cambridge, England, United Kingdom.
Huntingdon, England, United Kingdom 2 weeks ago
Regulatory Affairs Senior Specialist (m/f/d)
Cambridge, England, United Kingdom 3 weeks ago
Regulatory Affairs Manager – Oncology Cell Therapy
Cambridge, England, United Kingdom 3 weeks ago
Senior Manager of Regulatory and Quality - Diagnostics
Cambridge, England, United Kingdom 1 week ago
Regulatory Affairs Liaisons Manager- Global Therapeutic Area (TA)
Cambridge, England, United Kingdom 2 weeks ago
Sr. Manager, Regulatory Affairs Labeling Execution (Vendor Management)
Cambridge, England, United Kingdom 15 hours ago
Cambridge, England, United Kingdom 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr