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- Tasks: Join a dynamic team to manage global medical device registrations and ensure compliance.
- Company: Work with a leading client in the medical device industry, focused on innovation and quality.
- Benefits: Enjoy remote work flexibility and the chance to influence product development.
- Why this job: Be part of a crucial role that shapes healthcare products and impacts lives globally.
- Qualifications: Experience in medical device registrations is essential; leadership skills are a plus.
- Other info: This is a freelance position, offering a unique opportunity to work independently.
The predicted salary is between 43200 - 72000 £ per year.
Our client is looking for a freelance Senior Regulatory Specialist for a full-time contract focused on global medical device registrations.
Location: Remote
Position: Senior Regulatory Specialist/Manager
Focused on product registrations of Class IIa/IIb medical device products, globally. In addition, as an extended member of the development project team, the successful RA Specialist will have input into regulatory plans for new products.
Full role responsibilities include:
- Monitoring & analysing regulatory changes and implementing strategies for meeting new and changed requirements
- Liaison with internal and external stakeholders, providing training and support to ensure that regulatory requirements are met
- Preparing and submitting pre- and post-market reports to regulators and local representatives
- Planning and performing clinical evaluations of the company’s medical devices
- Maintaining Technical Documentation and ensuring that the company’s compliance with applicable standards, regulations and guidance is documented
- Acting as a lead auditor of internal functions and external suppliers
- Line manager/supervision for the Regulatory Affairs Coordinator
The ideal applicant:
Our client is looking for a Senior RA Specialist or Manager with thorough experience of medical device product registrations including via distributors.
Regulatory Specialist - Contract employer: Frey Consulting Group
Contact Detail:
Frey Consulting Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist - Contract
✨Tip Number 1
Familiarise yourself with the latest regulations and standards for Class IIa/IIb medical devices. Being well-versed in current guidelines will not only boost your confidence during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with medical device registrations. Engaging in discussions or attending webinars can provide valuable 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 hands-on experience will help you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Showcase your ability to work collaboratively with cross-functional teams. As a Regulatory Specialist, you'll need to liaise with various stakeholders, so emphasising your teamwork skills can make a positive impression.
We think you need these skills to ace Regulatory Specialist - Contract
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior Regulatory Specialist. Familiarise yourself with global medical device regulations and the specific requirements for Class IIa/IIb products.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, especially with medical devices. Include specific examples of your work with product registrations and any experience liaising with stakeholders or conducting clinical evaluations.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and how your background aligns with the company's needs. Mention your ability to monitor regulatory changes and implement strategies effectively.
Proofread Your Application: Ensure that your application is free from errors. A well-presented application reflects your attention to detail, which is crucial in regulatory affairs. Consider asking a friend or colleague to review it before submission.
How to prepare for a job interview at Frey Consulting Group
✨Know Your Regulations
Make sure you have a solid understanding of the regulations surrounding Class IIa and IIb medical devices. Brush up on the latest changes and be prepared to discuss how you've navigated these in your previous roles.
✨Showcase Your Experience
Be ready to share specific examples from your past work that demonstrate your expertise in regulatory submissions and compliance. Highlight any successful product registrations you've managed and the strategies you employed.
✨Prepare for Stakeholder Interaction
Since the role involves liaising with various stakeholders, think about how you can effectively communicate complex regulatory information. Prepare examples of how you've trained or supported teams in understanding regulatory requirements.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and challenges they face. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
