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- Tasks: Ensure compliance for medical devices and prepare regulatory submissions.
- Company: Join a leading company in the medical device industry.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Why this job: Make a difference in healthcare by ensuring device safety and compliance.
- Qualifications: Bachelor’s degree in life sciences and 3 years of medical device experience required.
- Other info: Dynamic team environment with a focus on innovation and quality.
The predicted salary is between 36000 - 60000 £ per year.
Responsibilities
- Determine and document change assessments for US Class II devices to ensure compliance with the US regulation.
- Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA.
- Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.
- Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the Notified Body.
- Support submission and maintenance of product registrations in markets worldwide.
- Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.
- Assist in external audits by supporting responses to auditor questions and requests.
- Keep abreast of new or changed regulations and standards and perform gap analyses.
- Perform additional duties as assigned.
Qualifications
- (REQUIRED) Bachelor’s degree, preferably in the life sciences; advanced degree a plus.
- (REQUIRED) At least 3 years of experience in medical device field, including hands-on experience with submissions.
- Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swissmedic, NMPA, PMDA, MFDS, and TGA.
- Experience with software-driven and electro-mechanical medical devices a plus.
- Strong knowledge of US and international requirements for regulatory submissions and maintenance of medical devices.
- Team player with ability to work independently in hybrid/in-person setting (Bedford, MA).
- Excellent and effective written and verbal communication skills.
- Excellent interpersonal skills, good judgment and analytical skills.
- Effective time management and organizational skills.
- Consistent, quality work and commitment to follow-through.
Regulatory Affairs Specialist in Bedford employer: Cedent Consulting
Contact Detail:
Cedent Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in Bedford
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of US and EU regulations. We recommend creating a cheat sheet of key points to discuss, especially around submissions and compliance. Show them you know your stuff!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills. Tailor your approach to each company!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. We believe it shows your enthusiasm and professionalism, making you stand out in a competitive field.
We think you need these skills to ace Regulatory Affairs Specialist in Bedford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially with US and EU medical device regulations. We want to see how your background aligns with the responsibilities listed in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can help us at StudySmarter. Be specific about your experience with submissions and compliance.
Showcase Your Communication Skills: Since effective communication is key in this role, make sure your application reflects your strong written skills. Keep your language clear and concise, and don’t forget to proofread for any typos!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Cedent Consulting
✨Know Your Regulations
Make sure you brush up on the latest US and EU regulations regarding medical devices. 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.
✨Prepare for Document Discussions
Since the role involves a lot of documentation, be ready to talk about your experience with submissions. Bring examples of documents you've worked on, and be prepared to explain your process for creating, revising, and compiling these materials.
✨Showcase Your Communication Skills
Effective communication is key in this role, especially when responding to regulatory bodies. Practice articulating your thoughts clearly and concisely, and consider preparing a few examples of how you've successfully navigated complex communications in the past.
✨Demonstrate Your Team Spirit
This position requires collaboration, so be ready to share examples of how you've worked effectively in teams. Highlight any experiences where you’ve had to balance independent work with team projects, especially in a hybrid setting.
