Senior Compliance Specialist — Medical Device Regulatory Affairs

🏢 ABOUT THE COMPANY

Medtronic, founded in 1949, is a global leader in medical technology, committed to alleviating pain, restoring health, and extending life for millions of people around the world. With over 90,000 employees, we operate in more than 160 countries. Our mission is to improve the lives of people around the world by taking a patient-centered approach to innovation. At Medtronic, we value innovation, teamwork, and customer satisfaction. We have been recognized for our commitment to diversity, equity, and inclusion.

🎯 ROLE OVERVIEW

As a Senior Compliance Specialist in Medical Device Regulatory Affairs, you will play a key role in ensuring that Medtronic's medical devices comply with global regulatory requirements. You will work closely with cross-functional teams to develop and implement compliance strategies, provide training and support to employees, and maintain accurate records of regulatory submissions. This role reports to the Director of Regulatory Affairs and has a significant impact on the company's reputation and compliance posture.

📋 KEY RESPONSIBILITIES

• Develop and implement compliance strategies for medical devices, including risk-based approaches to regulatory submissions and training programs for employees.

• Collaborate with cross-functional teams, including R&D, Marketing, and Manufacturing, to ensure compliance with global regulatory requirements.

• Provide training and support to employees on compliance policies and procedures.

• Maintain accurate records of regulatory submissions, including FDA clearance and CE marking.

• Develop and implement corrective action plans for non-compliance issues.

• Stay up-to-date with global regulatory developments and provide recommendations for changes to compliance policies and procedures.

• Conduct audits and assessments to ensure compliance with regulatory requirements.

• Develop and implement procedures for handling recalls and complaints.

• Collaborate with the Quality Assurance team to ensure compliance with quality management systems.

• Develop and implement metrics to measure compliance and quality.

• Provide input on regulatory strategy and policy development.

• Represent Medtronic in regulatory forums and working groups.

✅ REQUIRED QUALIFICATIONS

• Bachelor's degree in a life science or related field.

• 5+ years of experience in Regulatory Affairs, with a focus on medical devices.

• Advanced knowledge of regulatory requirements, including FDA and European Union regulations.

• Proven track record of developing and implementing compliance strategies.

• Excellent communication and interpersonal skills.

• Ability to work in a fast-paced environment and prioritize multiple tasks.

• Proficiency in Microsoft Office, particularly Excel and PowerPoint.

⭐ PREFERRED QUALIFICATIONS

• Master's degree in a life science or related field.

• Experience with QMS (Quality Management System) and auditing.

• Familiarity with Medtronic's products and technologies.

• Fluency in German or another European language.

• Certification in Regulatory Affairs, such as RAC or RAPS.

• Experience with project management methodologies, such as Agile or Scrum.

💰 WHAT WE OFFER

We offer a competitive salary range of €60,000 to €80,000 per year, depending on experience. We also offer a comprehensive benefits package, including health insurance, retirement plan, and generous vacation time. Our team is passionate about innovation and customer satisfaction, and we offer opportunities for professional growth and development. We are committed to a hybrid work model, with a mix of remote and in-office work.

👥 ABOUT THE TEAM

Our Regulatory Affairs team is a global team of highly motivated professionals who are passionate about ensuring that Medtronic's medical devices meet the highest standards of quality and compliance. We work collaboratively to achieve our goals and strive for excellence in everything we do. Our team is known for its expertise and knowledge of regulatory requirements, and we take pride in our ability to provide top-notch support to our colleagues and customers.

📨 HOW TO APPLY

If you are a motivated and detail-oriented professional with a passion for Regulatory Affairs, please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you!

📋 Job Details

Job Type	FULL TIME
Location	Munich, DE
Address	Bahnhofstraße 10, 80801
Salary	EUR 60,000 – 80,000 / year
Industry	General
Company	Medtronic
Valid Until	2026-09-13

📨 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.