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- Tasks: Ensure regulatory compliance in the Medical Device sector, focusing on In Vitro Diagnostics.
- Company: Join Medella Life, a leader in medical device innovation based in Cambridge.
- Benefits: Enjoy a hybrid work setup and competitive pay with potential for contract extension.
- Why this job: Be part of a dynamic team driving quality standards and making a real impact in healthcare.
- Qualifications: Bachelor's degree in a relevant field and experience in Regulatory Affairs for medical devices required.
- Other info: Opportunity for growth and permanent employment based on performance.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Regulatory Affairs Specialist (12-month Contract)
Location: Hybrid – Cambridge, UK
Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus on In Vitro Diagnostics (IVD). The position will be based in our Cambridge office, offering a hybrid work arrangement.
Key Responsibilities:
Regulatory Compliance:
- Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs.
- Monitor and interpret changes in regulations to ensure the company\’s products meet all requirements.
Submission Management:
- Prepare and submit regulatory documents, including 510(k) submissions, CE Mark applications, and other regulatory filings.
- Collaborate with cross-functional teams to gather necessary information for regulatory submissions.
Quality System Support:
- Contribute to the development and maintenance of the company\’s quality management system to ensure ongoing compliance.
- Participate in internal and external audits related to regulatory affairs.
Product Lifecycle Management:
- Support regulatory aspects of product development from concept through commercialisation.
- Provide regulatory input to product development teams and ensure compliance throughout the product lifecycle.
Communication and Collaboration:
- Liaise with regulatory authorities, notified bodies, and other relevant stakeholders.
- Collaborate with internal teams, including R&D, Quality Assurance, and Marketing, to achieve regulatory goals.
Qualifications:
- Bachelor\’s degree in a relevant scientific or engineering discipline.
- Proven experience in Regulatory Affairs within the Medical Device sector, with specific exposure to In Vitro Diagnostics (IVDs).
- Strong understanding of regulatory requirements, including FDA regulations, EU MDR, and other global regulatory frameworks.
- Experience with preparing and submitting regulatory documents and interacting with regulatory agencies.
- Excellent communication and interpersonal skills.
Desirable Skills:
- Familiarity with international regulatory requirements for medical devices.
- Previous experience in a hybrid work environment.
- Certifications in Regulatory Affairs would be an advantage.
Duration and Compensation: This is a contract position with a competitive rate with experience and qualifications. The selected candidate may have the opportunity for extension or permanent employment based on performance and company needs.
We look forward to receiving applications from qualified individuals who are passionate about maintaining high-quality standards and driving continuous improvement within our organisation.
Medella Life | Regulatory Affairs Specialist employer: Medella Life
Contact Detail:
Medella Life Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medella Life | Regulatory Affairs Specialist
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks relevant to In Vitro Diagnostics (IVDs). Understanding FDA regulations and EU MDR will give you a significant edge in discussions during the interview process.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, especially those who have experience in the Medical Device sector. Engaging with industry experts can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with regulatory submissions, particularly 510(k) and CE Mark applications. Be ready to share specific examples of how you've successfully navigated these processes in past roles.
✨Tip Number 4
Highlight your ability to collaborate with cross-functional teams. Emphasize any past experiences where you worked closely with R&D, Quality Assurance, or Marketing to achieve regulatory compliance.
We think you need these skills to ace Medella Life | Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Affairs Specialist position. Make sure you understand the key responsibilities and qualifications required, especially the focus on In Vitro Diagnostics (IVD).
Tailor Your CV: Customize your CV to highlight your relevant experience in Regulatory Affairs, particularly within the Medical Device sector. Emphasize any specific experience with IVDs and regulatory submissions like 510(k) or CE Mark applications.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for regulatory compliance and your understanding of the medical device industry. Mention how your skills align with the responsibilities outlined in the job description.
Highlight Communication Skills: Since the role involves liaising with regulatory authorities and collaborating with cross-functional teams, make sure to emphasize your excellent communication and interpersonal skills in both your CV and cover letter.
How to prepare for a job interview at Medella Life
✨Know Your Regulations
Make sure you have a solid understanding of the relevant regulatory standards, especially those related to In Vitro Diagnostics (IVDs). Be prepared to discuss specific regulations like FDA guidelines and EU MDR during your interview.
✨Showcase Your Experience
Highlight your previous experience in Regulatory Affairs within the Medical Device sector. Be ready to provide examples of regulatory submissions you've managed, such as 510(k) submissions or CE Mark applications.
✨Emphasize Collaboration Skills
Since the role involves working with cross-functional teams, demonstrate your ability to collaborate effectively. Share examples of how you've worked with R&D, Quality Assurance, or Marketing teams to achieve regulatory goals.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory compliance. Think about past challenges you've faced and how you navigated them to ensure compliance and successful product lifecycle management.
