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- Tasks: Lead regulatory submissions and ensure compliance for medical devices throughout their lifecycle.
- Company: Join a forward-thinking medical device organization making waves in the industry.
- Benefits: Enjoy a competitive salary, flexible remote work options, and great corporate perks.
- Why this job: Be part of a team driving innovation and market expansion in the medical device field.
- Qualifications: Must have experience with EU MDR and global medical device regulations.
- Other info: This role offers a chance to collaborate with cross-functional teams and influence product development.
The predicted salary is between 43200 - 72000 £ per year.
Job Title: Senior Regulatory Affairs Associate Location: West Yorkshire – some flexible remote Competitive Salary + Benefits Are you an experienced Regulatory Affairs professional with a solid understanding of EU MDR and global medical device regulations? We are recruiting a Senior Regulatory Affairs Associate to join a forward-thinking medical device organization. This role is essential in ensuring regulatory compliance across the product lifecycle, supporting market expansion, and driving successful regulatory submissions and approvals. The ideal candidate will bring technical expertise, attention to detail, and the ability to collaborate with cross-functional teams to maintain compliance and support product innovation. Key Responsibilities : Regulatory Submissions : Prepare and submit regulatory documentation for new products, modifications, and renewals, including CE Marking, 510(k), PMA, and international submissions. Regulatory Strategy : Develop and implement strategies for timely approvals, aligning with both U.S. and international requirements. Regulatory Compliance : Maintain compliance with medical device regulations, standards, and guidance documents throughout the product lifecycle. Stay updated on emerging regulatory changes and communicate key impacts. Qu…
Senior Regulatory Affairs Associate - Medical Devices employer: Clinical Selection Careers
Contact Detail:
Clinical Selection Careers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate - Medical Devices
✨Tip Number 1
Make sure to familiarize yourself with the latest updates on EU MDR and global medical device regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs space, especially those who have experience with medical devices. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory submissions and compliance. Highlighting your successes in navigating complex regulations will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams. Be ready to share how you've worked with different departments to ensure compliance and support product innovation, as this is a key aspect of the role.
We think you need these skills to ace Senior Regulatory Affairs Associate - Medical Devices
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Affairs Associate position. Highlight key responsibilities and required skills, such as knowledge of EU MDR and global medical device regulations, to tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with regulatory submissions, compliance, and strategy development in the medical device sector. Use specific examples that demonstrate your technical expertise and attention to detail.
Showcase Collaboration Skills: Since the role requires collaboration with cross-functional teams, include examples in your application that illustrate your ability to work effectively with others. Mention any relevant projects where you successfully collaborated to achieve regulatory goals.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's mission and how your background aligns with their needs. Address how you can contribute to maintaining compliance and supporting product innovation within their organization.
How to prepare for a job interview at Clinical Selection Careers
✨Show Your Regulatory Knowledge
Make sure to brush up on your knowledge of EU MDR and global medical device regulations. Be prepared to discuss specific examples of how you've navigated these regulations in past roles.
✨Demonstrate Attention to Detail
Since this role requires a high level of detail, be ready to share instances where your attention to detail made a significant impact on regulatory submissions or compliance efforts.
✨Highlight Cross-Functional Collaboration
Prepare to talk about your experience working with cross-functional teams. Share examples of how you’ve collaborated with R&D, quality assurance, and marketing to ensure regulatory compliance.
✨Stay Updated on Regulatory Changes
Show that you are proactive about staying informed on emerging regulatory changes. Discuss any recent updates you’ve followed and how they could impact the organization’s compliance strategies.
