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- 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 grow in a dynamic field.
- Why this job: Make a real impact in healthcare by ensuring product compliance and safety.
- Qualifications: In-depth regulatory knowledge and strong communication skills required.
- Other info: Join a collaborative team in Oxfordshire with excellent career growth potential.
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 employer: CY Partners
Contact Detail:
CY Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical devices field and let them know you're on the hunt for a Regulatory Affairs Manager role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EMA regulations. Be ready to discuss how you've successfully managed submissions in the past. We want to see that you can handle the pressure and keep things compliant!
✨Tip Number 3
Show off your collaboration skills! During interviews, highlight examples of how you've worked with cross-functional teams. This role requires a lot of teamwork, so we need to know you can play nice with others while getting the job done.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our exciting team in Oxfordshire.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially with FDA and EMA submissions. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Communication Skills: Since strong written communication is key for this role, ensure your application is clear, concise, and free of jargon. We love a well-structured document, so take the time to proofread and polish your writing before hitting send.
Highlight Your Project Management Experience: This role involves managing multiple projects, so be sure to mention any relevant project management experience. We’re looking for examples that demonstrate your ability to prioritise tasks and meet deadlines effectively.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our 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 regulatory requirements and how they apply to medical devices 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 compliance checks, 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 teams like manufacturing or quality assurance. Be ready to share how you navigated challenges and ensured smooth communication, as this role requires a lot of teamwork and coordination.
✨Prepare for Authority Interaction Scenarios
Anticipate questions about how you would handle interactions with health authorities. Consider discussing any past experiences where you communicated with regulatory bodies, and be prepared to outline your approach to managing queries and submissions effectively.
