Senior Global Medical Device Regulatory Affairs Specialist — EU Compliance

🏢 ABOUT THE COMPANY

Medtronic is a pioneering medical technology company founded in 1949 with a mission to alleviate pain, restore health, and extend life for millions of people worldwide. With a global presence and a team of over 90,000 employees, we are committed to innovation, collaboration, and making a positive impact on people's lives. We are proud of our 73-year history and our achievements in revolutionizing healthcare through groundbreaking technology. Our diverse and inclusive culture values creativity, integrity, and teamwork, making us a great place to work.

🎯 ROLE OVERVIEW

As a Senior Global Medical Device Regulatory Affairs Specialist, you will play a critical role in ensuring that our medical devices comply with EU regulations and directives. You will work closely with cross-functional teams, including R&D, clinical affairs, and quality assurance, to develop and implement regulatory strategies that meet the evolving needs of our customers and patients. You will be responsible for managing regulatory submissions, responding to regulatory inquiries, and maintaining a thorough understanding of EU regulatory requirements.

📋 KEY RESPONSIBILITIES

Develop and implement EU regulatory strategies to ensure compliance with EU directives and regulations.

Collaborate with R&D, clinical affairs, and quality assurance teams to ensure regulatory requirements are integrated into product development.

Manage and maintain a comprehensive understanding of EU regulatory requirements, including CE marking, MDR, and IVDR.

Develop and submit regulatory submissions, including technical files and clinical evaluation reports.

Respond to regulatory inquiries, including requests for information and audits.

Maintain accurate and up-to-date records of regulatory correspondence and submissions.

Provide training and support to colleagues on EU regulatory requirements.

✅ REQUIRED QUALIFICATIONS

8+ years of experience in regulatory affairs, with a focus on EU medical device regulations.

Bachelor's degree in a relevant field, such as regulatory affairs, life sciences, or a related field.

Proven experience with EU regulatory submissions, including CE marking, MDR, and IVDR.

Excellent communication and project management skills, with the ability to work independently and collaboratively.

Knowledge of EU regulatory requirements, including directives and regulations.

⭐ PREFERRED QUALIFICATIONS

Master's degree in a relevant field.

Certification in regulatory affairs, such as RAC or CQIA.

Experience with medical device software and digital health technologies.

Knowledge of global regulatory requirements, including FDA and ISO.

💰 WHAT WE OFFER

Competitive salary range: €60,000 - €80,000 per year.

Comprehensive health insurance and retirement plan.

Generous vacation days and flexible work arrangements.

Annual learning and development budget for training and conference attendance.

Remote work policy with opportunity to work from home.

Collaborative team culture with regular team-building events.

Opportunities for career growth and professional development.

👥 ABOUT THE TEAM

Our team is a diverse group of regulatory affairs professionals with expertise in EU and global regulations. We work collaboratively to ensure that our medical devices meet the highest standards of quality and safety. Our team is passionate about regulatory affairs and is committed to staying up-to-date with the latest developments in EU regulations.

📨 HOW TO APPLY

Please submit your application, including your resume and a cover letter, to [insert contact email]. We look forward to receiving your application. Expected response timeline is within 2 weeks of application submission.

📋 Job Details

Job Type	🌐 Remote
Location	Remote, DE
Address	Bahnhofstraße 12, 80331
Salary	EUR 60,000 – 80,000 / year
Industry	General
Company	Medtronic
Valid Until	2026-09-14

📨 How to Apply

Submit your updated CV and a brief cover letter to Medtronic. Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted within 2 weeks of applying.