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Principal Regulatory Specialist, EMEA Regulatory Affairs

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): 

Ratingen, DE

Additional Locations: Netherlands-Kerkrade

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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 acquisition integration, reporting to the responsible Manager. This role will provide support to the EMEA regulatory team related to all aspects of acquisition integration. The person may also be required to support other aspects of the EMEA team, including local registration and post-market activities. 
 
Key Responsibilities:

•    Support EMEA Regulatory Affairs acquisition integration activities in a matrixed organization.   
•    Coordinates with EMEA RA Management in establishing project priorities, allocating deadlines.
•    Develops and utilizes relationships, tools, processes and other resources to assist in solving problems and gain efficiencies 
•    Collaborate with EMEA RA and associated teams to develop efficiency tools/processes to better manage acquisition activities.
•    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.  
 
Required Qualifications:

•    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
•    Ability to work independently with minimal supervision 
•    Demonstrated success as the lead on cross-functional teams
•    Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)
 
Preferred Qualifications:

•    Working knowledge of EU and/or international medical device regulations or experience in similar regulated industry/environments
•    Experience of both pre and post-market regulatory activities
•    Working knowledge of MDR 
 

 

Requisition ID: 543942

 

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!


Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, Legal, Healthcare, Research

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