Regulatory Affairs Specialist, EMEA

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Location: in our offices in Madrid, Spain, on a hybrid working schedule (3 days per week in the office + 2 days per week working from home).

About the role:

The Clinical Center of Excellence (CoE) is part of the EMEA Regulatory Affairs team and provides regulatory expertise and support for clinical investigations conducted across all divisions in EMEA. The Clinical CoE also drives regulatory intelligence by monitoring and ensuring timely assessment of evolving Competent Authority expectations and translating requirements into practical, scalable processes for conducting clinical investigations in EMEA.

The Regulatory Affairs Specialist is responsible for coordinating and executing assigned regulatory activities throughout the lifecycle of clinical investigations. This includes preparing and submitting Competent Authority submission and notification dossiers, responding to Competent Authority questions, submitting required safety reports, maintaining regulatory files and tracking systems, and completing ongoing regulatory maintenance activities.

In this role, you will work cross-functionally to help ensure submission and notification quality, regulatory compliance, timely delivery, and accurate documentation across assigned clinical investi gations.

In this role, you will be responsible to:

• Prepare, review, submit and file application dossiers for clinical investigations with Competent Authorities and regulatory agencies.
• Maintain accurate and up-to-date regulatory files and tracking databases as required.
• Prepare, submit and file communications with Competent Authorities and regulatory agencies as needed, including responses to follow-up questions.
• Prepare, submit and file required safety reporting information with Competent Authorities and regulatory agencies.
• Participate in cross-functional meetings related to clinical investigations.
• Participate in regulatory intelligence monitoring and assessment activities.

What are we looking for in you:

• Minimum of 2 years' experience in regulatory affairs, including hands-on experience with clinical investigation submissions for medical devices.
• Working knowledge of ISO 14155, EU MDR 2017/745, MDCG 2021-6 and MDCG 2020-10/1, as well as other national or global regulations related to clinical investigations.
• Excellent written and verbal communication skills in English.
• Strong organizational and analytical skills, with the ability to manage sequential regulatory activities, prioritize effectively and apply sound problem-solving skills.
• Demonstrated resilience, with the ability to remain effective and solutions-focused when managing competing priorities, challenging situations and a fast-paced clinical environment.
• Ability to work effectively in a cross-functional, fast-paced and collaborative environment.
• Nice-to-have demonstrated project management experience within a regulated environment.

What We Can Offer to You:

• Contract Type: Permanent Contract.
• Comprehensive benefitpackage, designed to support your health, well-being and financial future, including:
  • Private Health and Life Insurance.
  • Attractive Pension plan.
  • Ticket Restaurants.
• Healthy work-life balance with flexibility and respect for personal time.
• Working in an international environment with diverse, high-performing colleagues.
• Inspirational colleagues & culture that empower creativity, accountability, and excellence.
• Career Development opportunities through dedicated training programs and stretch assignments.

We, Boston Scientific, are an equal employment opportunity employer. We do not and will not make any personnel decisions (like recruiting, hiring, job assignments, and promotions) based on a person’s age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

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