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- Tasks: Lead clinical documentation and regulatory submissions for EU MDR compliance.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on patient outcomes through innovative medical treatments.
- Qualifications: 8+ years in regulatory affairs with strong knowledge of EU MDR.
- Other info: Dynamic role with multi-country collaboration and career advancement opportunities.
The predicted salary is between 48000 - 72000 £ per year.
We are seeking a highly skilled and detail-oriented Associate Director of Regulatory Affairs to lead clinical documentation and regulatory submission activities in support of EU MDR compliance. This strategic role will oversee the preparation, finalization, and lifecycle management of clinical and regulatory documents, with a focus on services across the UK, Netherlands, and Denmark.
Key Responsibilities
- Clinical Documentation & Planning
- Lead the drafting and lifecycle management of Clinical Investigation Plans (CIP).
- Prepare and maintain Master Patient Informed Consent (PIC) Forms in alignment with EU MDR and local regulatory requirements.
- Develop and manage Investigational Medical Device Dossiers and Investigator’s Brochures.
- Safety & Risk Management
- Draft and manage Safety Plans and oversee Safety Reporting for both prospective and post-market studies.
- Prepare Clinical Study Progress Reports and Close-Out Reports.
- Regulatory Submissions
- Draft, finalize, and manage Master Submission Documents for National Competent Authorities, Ethics Committees, and IRBs/IECs.
- Review and revise sponsor-provided submission documents to ensure regulatory compliance and consistency.
- Prepare and manage Amendment Submission Documents for protocol or study changes.
Qualifications
- Minimum 8 years of experience in regulatory affairs or medical device submissions.
- Strong knowledge of EU MDR, ISO 14155, and relevant regulatory frameworks.
- Proven experience managing multi-country clinical submissions and working with Competent Authorities and Ethics Committees.
- Exceptional written and verbal communication skills.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Associate Regulatory Affairs Director employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Regulatory Affairs Director
✨Tip Number 1
Network like a pro! Reach out to professionals in regulatory affairs 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 EU MDR and ISO 14155 regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your knowledge and confidence.
✨Tip Number 3
Showcase your experience with multi-country submissions! We suggest preparing specific examples of your past work that highlight your skills in managing complex regulatory processes across different regions.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge over other candidates. Let’s get you that Associate Regulatory Affairs Director role!
We think you need these skills to ace Associate Regulatory Affairs Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Regulatory Affairs Director role. Highlight your experience with clinical documentation and regulatory submissions, especially in relation to EU MDR compliance. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that relate to the key responsibilities listed in the job description. We love a good story that showcases your passion for regulatory affairs.
Showcase Your Communication Skills: Since exceptional written communication is key for this position, make sure your application is clear and concise. Avoid jargon and keep it professional yet approachable. We appreciate a well-structured application that reflects your ability to communicate effectively.
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about StudySmarter and what we stand for!
How to prepare for a job interview at IQVIA
✨Know Your Regulations
Make sure you brush up on the EU MDR and ISO 14155 regulations before your interview. Being able to discuss these frameworks confidently will show that you’re not just familiar with them, but that you can apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed clinical documentation or regulatory submissions. Highlight any multi-country projects you've worked on, as this aligns perfectly with the job requirements.
✨Communicate Clearly
Since exceptional communication skills are a must for this role, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to get comfortable discussing complex topics in an easy-to-understand way.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to regulatory affairs and how they handle compliance across different countries. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
