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- Tasks: Prepare and submit global regulatory applications for medical devices across various countries.
- Company: Join Kaye/Bassman International, a leader in biotech and medical device recruitment.
- Benefits: Enjoy medical insurance, tuition assistance, and flexible work options.
- Why this job: Be part of a dynamic team impacting global health with innovative medical devices.
- Qualifications: Bachelor's degree in science or engineering; 5-10 years in regulatory affairs required.
- Other info: Experience with Class II electro-mechanical devices is essential.
The predicted salary is between 43200 - 72000 £ per year.
The Senior Regulatory Affairs Specialist will be responsible for preparing and submitting global regulatory applications in countries such as Japan, India, China, Saudi Arabia, Australia, Mexico, and Brazil. In this role, you will support U.S. Medical submissions by collaborating closely with the Director of Regulatory Affairs.
Responsibilities:
- Filing regulatory submissions 510k, EU MDR, IDEs.
- Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Assess design and manufacturing changes for compliance with applicable regulations and effect on global registrations.
- Maintain regulatory files and tracking databases as needed.
- Support quality system audits by notified bodies, government agencies, and customers.
- Obtain Medical Device Certificates to Foreign Government (CFGs).
- Support post-market surveillance, including preparation of post-market clinical follow-up plans and reports.
- Participate in the review of complaints and all other post-market-release feedback.
Requirements:
- A bachelor's degree in the scientific or engineering field; an advanced degree is preferred.
- 5-10 years of experience with global regulatory submissions and management of Class II electro-mechanical medical devices.
- Class II electro-mechanical experience required.
- Regulatory affairs experience generating applications and expertise in collaboration with internal and external partners to answer subsequent questions.
- Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366.
- Experience with lasers and optical technologies is desired but not necessary.
- Strong working knowledge of Microsoft Word and Excel.
Senior Regulatory Affairs Specialist – Medical Device employer: Kaye/Bassman International
Contact Detail:
Kaye/Bassman International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist – Medical Device
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for the countries mentioned in the job description. Understanding the nuances of global submissions can set you apart from other candidates.
✨Tip Number 3
Consider reaching out directly to the hiring manager or recruiter via LinkedIn. A polite message expressing your interest in the role and highlighting your relevant experience can make a memorable impression.
✨Tip Number 4
Stay updated on the latest changes in regulations related to Class II electro-mechanical medical devices. Being knowledgeable about current compliance standards will demonstrate your commitment and expertise during interviews.
We think you need these skills to ace Senior Regulatory Affairs Specialist – Medical Device
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Regulatory Affairs Specialist position. Familiarise yourself with the specific responsibilities and requirements, such as experience with global regulatory submissions and knowledge of relevant regulations.
Tailor Your CV: Customise your CV to highlight your experience in regulatory affairs, particularly with Class II electro-mechanical medical devices. Emphasise any relevant projects or achievements that align with the job's requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific experiences that demonstrate your ability to handle global regulatory submissions and compliance.
Highlight Relevant Skills: In your application, make sure to highlight your skills in design controls, risk management practices, and familiarity with regulations like FDA QSRs and ISO standards. This will show that you are well-equipped for the role.
How to prepare for a job interview at Kaye/Bassman International
✨Know Your Regulations
Familiarise yourself with the specific regulations relevant to medical devices, such as FDA QSRs and ISO standards. Be prepared to discuss how your experience aligns with these regulations and how you have successfully navigated them in past roles.
✨Showcase Your Experience
Highlight your 5-10 years of experience in global regulatory submissions, especially with Class II electro-mechanical devices. Use specific examples to demonstrate your expertise in preparing and submitting applications, and how you've collaborated with internal and external partners.
✨Prepare for Technical Questions
Expect technical questions related to design controls, risk management practices, and post-market surveillance. Brush up on your knowledge of these areas and be ready to explain how you've applied them in your previous positions.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and challenges they face in different markets. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
