Regulatory Affairs Specialist - Post-Market Surveillance (PMS) Center of Excellence (CoE), EMEA

Boston Scientific Gruppe; Düsseldorf; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A global medical solutions company is seeking a Regulatory Affairs Specialist to support post-market surveillance activities in Düsseldorf. This role involves ensuring compliance with EU regulations and coordinating with various teams to optimize processes. The ideal candidate will have a Bachelor’s degree, 2+ years in Regulatory Affairs, and strong communication skills. Fluency in English is essential, and additional languages are advantageous.

Qualifikationen

• 2+ years of experience in Regulatory Affairs, preferably with exposure to post-market activities.
• Ability to work in a matrixed, multicultural environment.
• Additional EMEA languages are a plus.

Aufgaben

• Support the preparation of PMS documents like FSCA reports.
• Coordinate with local RA teams to gather post-market data.
• Contribute to continuous improvement initiatives within the CoE.

Kenntnisse

Strong organizational skills

Strong communication skills

Familiarity with EU MDR

Fluency in English

Ausbildung

Bachelor’s degree in Life Sciences, Engineering, or related field

Jobbeschreibung

Regulatory Affairs Specialist - Post-Market Surveillance (PMS) Center of Excellence (CoE), EMEA

Onsite Location(s):

Dusseldorf, NW, DE

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Regulatory Affairs Specialist – Post-Market Surveillance (PMS) Center of Excellence (CoE), EMEA

THIS ROLE CAN BE BASED IN MILAN, MADRID, LONDON, PARIS, DUSSELDORF, WARSAW

About the role:

As a Regulatory Affairs Specialist within the EMEA PMS CoE, you will support the execution of post-market surveillance activities across the region. You will contribute to the implementation of a harmonized and efficient PMS operating model, ensuring compliance with EU MDR and other applicable regulations. This role is critical to strengthening the CoE’s capacity and enabling the transition of responsibilities from local RA teams to the centralized structure.

Your responsibilities will include:

• Support the preparation of PMS documents, such as FSCA reports, FSN /customer letters and responses to competent authorities questions.
• Support in addressing vigilance additional information requests originating from Competent Authorities within the Central/Western cluster.
• Coordinate with local RA teams, QA, and Field Action teams to gather post-market data.
• Assist in the development and maintenance of templates and tracking systems and KPIs.
• Ensure timely and accurate submissions to Competent Authorities in line with regulatory requirements.
• Contribute to continuous improvement initiatives within the CoE, including process optimization and knowledge sharing.
• Maintain up-to-date knowledge of applicable regulations.
• Contribute to regulatory intelligence on PMS related topics.

What are we looking for in you?

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in Regulatory Affairs, preferably with exposure to post-market activities.
• Familiarity with EU MDR, vigilance reporting, and FSCA processes.
• Strong organizational and communication skills.
• Ability to work in a matrixed, multicultural environment.
• Fluent in English; additional EMEA languages are a plus.

Interested? Please apply online with yourCV in English

Requisition ID:613974

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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