At a Glance
- Tasks: Lead regulatory activities for medical devices and drug-device combination products.
- Company: Vectura Group is a global leader in innovative inhaled therapies.
- Benefits: Enjoy a dynamic work environment with opportunities for professional development.
- Other info: Join a collaborative culture dedicated to achieving excellence in healthcare.
- Why this job: Make a real impact on patient care while working with cutting-edge technology.
- Qualifications: Experience in Regulatory Affairs, especially with medical devices and DDCPs, is essential.
The predicted salary is between 36000 - 60000 € per year.
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
- 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!
Manager, Regulatory Affairs (Medical Devices & Drug Device Combination Products) in Cambridge employer: The Law Offices of James A. Flexer
Vectura Group is an exceptional employer, offering a vibrant work culture that fosters innovation and collaboration in the medical technology sector. Located in Cambridge, employees benefit from a dynamic environment with ample opportunities for professional growth, while contributing to meaningful advancements in patient care through cutting-edge inhaled therapies and drug-device combination products.
Contact Detail:
The Law Offices of James A. Flexer Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Regulatory Affairs (Medical Devices & Drug Device Combination Products) in Cambridge
✨Tip Number 1
Familiarise yourself with the Medical Device Directive (MDD) and Medical Device Regulations (MDR). Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the role and the industry.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices and drug-device combination products. Attend relevant conferences or webinars to make connections and gain insights that could be beneficial during the application process.
✨Tip Number 3
Stay updated on recent changes in global regulatory frameworks and standards. Being knowledgeable about current trends and updates can give you an edge in discussions with interviewers and show that you are proactive in your professional development.
✨Tip Number 4
Prepare to discuss specific projects where you've successfully navigated regulatory challenges. Highlighting your problem-solving skills and project management experience will resonate well with the hiring team at Vectura.
We think you need these skills to ace Manager, Regulatory Affairs (Medical Devices & Drug Device Combination Products) in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in regulatory affairs, particularly with medical devices and drug-device combination products. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter:Write a cover letter that showcases your passion for regulatory affairs and your understanding of the industry. Mention specific experiences that align with the responsibilities listed in the job description, such as your familiarity with MDD and MDR.
Highlight Cross-Functional Collaboration:Emphasise your ability to work collaboratively with different teams, such as quality assurance and engineering. Provide examples of past projects where you successfully navigated cross-functional dynamics to achieve regulatory compliance.
Showcase Regulatory Intelligence:Demonstrate your knowledge of current regulatory trends and changes. Mention any relevant training or certifications you have, and how you stay updated on global regulatory frameworks, which is crucial for the role.
How to prepare for a job interview at The Law Offices of James A. Flexer
✨Know Your Regulations
Familiarise yourself with the Medical Device Directive (MDD) and Medical Device Regulations (MDR). Be prepared to discuss how these regulations impact product approvals and compliance, as this will demonstrate your expertise in regulatory affairs.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with teams across regulatory, quality assurance, and engineering. Provide examples of how you’ve successfully collaborated on projects, as this role requires seamless teamwork to ensure compliance throughout product development.
✨Prepare for Technical Questions
Expect questions about authoring MDR Technical Files and Design Dossiers. Brush up on your knowledge of regulatory submissions and be ready to explain your process for preparing and submitting documentation to regulatory authorities.
✨Stay Updated on Regulatory Changes
Demonstrate your commitment to staying informed about global regulatory changes and new standards. Discuss any recent updates you've followed and how they could impact the company’s products, showing that you’re proactive in adapting to evolving landscapes.
