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- Tasks: Manage regulatory compliance for medical devices and support quality processes.
- Company: Join a leading US medical device company focused on innovation and patient care.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and development.
- Why this job: Be part of a team that impacts healthcare while developing your skills in a fast-paced setting.
- Qualifications: Bachelor's degree required; experience in medical devices or IVD regulation preferred.
- Other info: Located in Dundee, this role requires an EU work permit.
The predicted salary is between 36000 - 60000 £ per year.
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Regulatory Affairs Specialist (IVD), Dundee
Client:
Guided Solutions
Location:
Dundee, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
9d93e43aeee0
Job Views:
6
Posted:
17.06.2025
Expiry Date:
01.08.2025
Job Description:
Our client is a US-headquartered multinational medical device business with a market-leading presence across multiple healthcare disciplines. The business runs in a state of perpetual innovation, continually developing new technologies and enhancing the patient experience. Due to their continued growth, they are now looking for a Regulatory Affairs Specialist to join their Dundee office.
As a Regulatory Affairs Specialist, you will be primarily responsible for the administration and development of the Switzerland Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (RP) activities within the company\’s diagnostics division according to appropriate procedures and processes.
Key responsibilities:
- Ensure that appropriate oversight of activities is maintained and any updates required are actioned through appointed Quality Management system(s).
- Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
- Act as an initial and ongoing point of contact for customer sites, external regulators, and other parties for Swiss PRRC and UK RP-related requests.
- Collation of electronic and paper documents to allow the registration or removal of products according to procedures.
- Review and update internal/external databases’ details for products and manufacturers.
- Administer, deliver, and forward documents related to requests from manufacturers.
- Communicate any complaints, as appropriate to manufacturers.
To be considered for the role, you must closely match the following criteria:
- Experience in medical devices or IVD regulation or regulatory activities.
- Bachelor’s Degree in a related field is required.
- Experience of PRRC activities previously is desirable but not essential.
- Experience as a user in MS Office suite.
- Excellent administrative, organisational and business support skills, with the ability to multi-task and work calmly under pressure.
- Ability to coordinate meetings, drive results, and build relationships.
- Demonstrated administrative, written and verbal communication, negotiation, and influencing skills.
- Organized, detail-oriented, with a high level of confidentiality.
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Regulatory Affairs Specialist (IVD) employer: Guided Solutions
Contact Detail:
Guided Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist (IVD)
✨Tip Number 1
Familiarise yourself with the specific regulations and standards related to IVDs, such as ISO and FDA guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices or IVDs. Attend industry events or join relevant online forums to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss your organisational and multitasking skills during the interview. Think of specific examples where you've successfully managed multiple tasks or projects, as this is crucial for the role.
✨Tip Number 4
Research the company’s recent innovations and developments in the medical device sector. Being knowledgeable about their products and initiatives will show your genuine interest and help you stand out during the interview process.
We think you need these skills to ace Regulatory Affairs Specialist (IVD)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Specialist in the IVD sector. Familiarise yourself with the key requirements and expectations outlined in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience in medical devices or IVD regulation. Emphasise any previous roles that involved regulatory activities, as well as your educational background in a related field.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the industry. Mention specific experiences that demonstrate your skills in administration, organisation, and communication, which are crucial for this role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential for a role in regulatory affairs.
How to prepare for a job interview at Guided Solutions
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to IVDs, such as ISO and FDA guidelines. Being able to discuss these in detail will show your expertise and commitment to the role.
✨Demonstrate Your Organisational Skills
Prepare examples that showcase your ability to manage multiple tasks and maintain organisation under pressure. This is crucial for a Regulatory Affairs Specialist, so be ready to discuss how you handle competing priorities.
✨Showcase Your Communication Skills
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly. Be prepared to provide examples of how you've effectively communicated complex information in previous roles.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle specific regulatory challenges or compliance issues. Think through potential scenarios and how you would approach them, demonstrating your problem-solving skills.
