At a Glance
- Tasks: Manage regulatory submissions and ensure compliance with FDA and EU regulations.
- Company: Exciting medical devices organisation with innovative products in clinical trials.
- Benefits: Hybrid working opportunities and a chance to work on impactful projects.
- Other info: Dynamic environment with opportunities for professional growth.
- Why this job: Join a growing team and make a difference in the medical devices field.
- Qualifications: In-depth knowledge of regulatory requirements and strong communication skills.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs manager – Medical Devices
A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions
As an experienced Regulatory Affairs professional, you’ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities.
The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.
Key Responsibilities
- Submission Strategy:
Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications.
- Document Preparation:
Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as Chemistry, Manufacturing, and Controls (CMC) data, study reports, and other regulatory materials.
- Regulatory Compliance:
Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and European Medicines Agency (EMA).
- Cross-Functional Coordination:
Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for submissions.
- Authority Interaction:
Communicating with health authorities (e.g., FDA, EMA) regarding submissions, queries, and regulatory matters.
- Post-Approval Maintenance:
Managing ongoing regulatory activities such as post-approval variations, annual reports, and changes to product manufacturing.
Required Skills & Qualifications
- Regulatory Knowledge: In-depth understanding of FDA and EU regulatory requirements for pharmaceutical products or medical devices.
- Technical Skills: Proficiency in regulatory document management systems and MS Office applications.
- Communication: Strong written and verbal communication skills in English.
- Project Management: Ability to manage multiple projects, meet deadlines, and prioritize tasks effectively.
- Collaboration: A collaborative team player with cultural awareness and adaptability.
This is an exciting opportunity at a growing medical devices organisation. The facility is based in Oxfordshire and offers hybrid working opportunities.
We look forward to receiving your application.
CY Partners is acting as an Employment Business / Agency in relation to this vacancy.
Regulatory Affairs Manager in Banbury employer: CY Partners
Join a dynamic and innovative medical devices organisation in Oxfordshire, where your expertise as a Regulatory Affairs Manager will be valued and nurtured. With a strong focus on employee growth, the company fosters a collaborative work culture that encourages strategic thinking and cross-functional teamwork, while offering hybrid working opportunities to ensure a healthy work-life balance. Be part of a team that is at the forefront of medical advancements, contributing to meaningful projects that make a real difference in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in Banbury
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those working with medical devices. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EMA regulations. Be ready to discuss your experience with submissions and compliance, as these are key topics for the role of Regulatory Affairs Manager.
✨Tip Number 3
Showcase your project management skills! Be prepared to share examples of how you've successfully managed multiple projects and collaborated with cross-functional teams in your previous roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Regulatory Affairs Manager in Banbury
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Affairs Manager role. Highlight your experience with FDA and EU submissions, and show us how your skills align with the job description.
Showcase Your Regulatory Knowledge:We want to see your in-depth understanding of regulatory requirements. Include specific examples of past projects where you’ve successfully navigated compliance with FDA or EMA regulations.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it’s relevant to the role. We appreciate a well-structured document that’s easy to read!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity in our growing team.
How to prepare for a job interview at CY Partners
✨Know Your Regulations
Make sure you brush up on the latest FDA and EMA regulations before your interview. Being able to discuss specific compliance requirements and how they relate to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Document Skills
Prepare examples of regulatory documents you've worked on in the past. Whether it's submission strategies or document reviews, having concrete examples ready will demonstrate your hands-on experience and attention to detail, which are crucial for this role.
✨Highlight Cross-Functional Collaboration
Think of instances where you've successfully collaborated with other teams, like manufacturing or quality assurance. Be ready to share how you navigated challenges and ensured smooth communication, as this is key in a role that requires coordination across various departments.
✨Engage with Authority Interaction
Be prepared to discuss your experience liaising with health authorities. If you have any anecdotes about navigating queries or submissions, share them! This will illustrate your ability to handle authority interactions effectively, which is a vital part of the job.
