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Senior Regulatory Specialist, EMEA Regulatory Affairs (Clinical Investigation Support)

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Warsaw, PL

Hiring Manager: Claire Mary Rose Mackenzie-Owen
Recruiter: Katarzyna Soltysiak


At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.




Senior Regulatory Specialist, EMEA Regulatory Affairs (Clinical Investigation Support)



Remote Eligible:  Remote in Country

Onsite Location(s):  Poland, Germany, UK

Additional Location(s): EMEA




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.


Team Purpose: The EMEA Regulatory Affairs team is a strategic partner that supports, delivers and sustains business and regulatory solutions for customers.


This is a key role supporting clinical investigations for the entire Boston Scientific product portfolio, reporting to the responsible Manager. Within the EMEA Regulatory Affairs organization, the main objectives of the role will be to contribute to successful business goals by supporting regulatory activities linked to pre- and post-market clinical studies, as well as all associated safety reporting in the EMEA region. 




Your responsibilities will include:


•    Support the strategy and conduction of clinical studies in the EMEA region.
•    Coordinate the preparation, review, and submission of clinical study files from the first

     submission to the closure of the studies, allocating deadlines.
•    Collaborate with EMEA RA, clinical and safety teams to develop efficiency tools/processes to

     better manage clinical investigations.

•    Serve as regulatory consultant to clinical and safety teams as required.
•    Supports Quality System and audit readiness through data maintenance and compliance  checks of owned processes.
•    Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  



Qualifications & Experiences:


•    Minimum of a Bachelor’s degree 
•    Minimum of 4 years’ experience working under a medical device quality system 
•    Prior experience leading and/or managing projects
•    Excellent written and oral communication in English. Other language skills are an advantage
•    Excellent research and analytical skills
•    Ability to manage multiple projects simultaneously 
•    Proven collaboration and influencing skills 
•    Ability to collaborate with cross-functional partners/teams
•    Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)



Preferred Qualifications:


•    Working knowledge of EU and/or international medical device regulations and clinical study regulations
•    Working knowledge of MDR


We offer:


  • Our company offers full time job in an international environment with attractive benefits package, competitive salary and a permanent employment contract. We also offer trainings and development tailored to employee’s need


Discover benefits tailored to you => Benefits




Requisition ID: 549558

Job Segment: Clinic, Investigation, Clinical Research, Medical Research, Regulatory Affairs, Healthcare, Legal

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