Senior Regulatory Affairs Manager

Location:

Kerkrade – Netherlands

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Information Technology Jobs

Other Industries & Skills: 

Aerospace Legal

Advertiser:

Boston Scientific

Job ID:

127161468

Posted On: 

17 May 2023

Additional Locations: Netherlands-Kerkrade; France-Voisins le Bretonneux; Germany-Düsseldorf; Germany-Ingolstadt; Germany-Köln; Germany-Ratingen; Ireland-Galway; Italy-Milan; Netherlands-Maastricht; Poland-Warsaw; Spain-Madrid; United Kingdom-Hemel Hempstead

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.

About the role:
The EMEA Regulatory Affairs (RA) team is a strategic partner that supports, delivers and sustains business and regulatory solutions for customers.
 
This role is considered part of the EMEA RA Leadership team, reporting to the Director of EMEA RA. This role will manage and provide leadership to the EMEA Regulatory Operations (OPS) team as well as support the overall vision and goals of the Regulatory organization. This team is a group of subject matter experts (SME’s) that advocate for the Regulatory function and support shared services related LibRA, digital health, new and evolving regulations, advocacy, EUDAMED and other regional support needs to improve the overall effectiveness of the Regulatory Affairs function. This role is also responsible for representing EMEA RA regulatory interests within allocated global regulatory initiatives, process ownership and audit support.

Your responsibilities include:

-Lead EMEA Regulatory Affairs Operations team in a matrixed organization.  
-Encourages and facilitates professional development of direct reports.
-Hires, evaluates, and trains direct reports.
-Establishes and manages with EMEA RA Management project priorities, allocating resources and workload.
-Provides regulatory expertise with respect to global and regional regulatory strategy development, execution, and risk management.
-Develops and utilizes relationships, tools, processes, and other resources to assist in solving problems and gain efficiencies through EMEA wide RA initiatives
-Collaborates with Regulatory Affairs functional peers from across BSC to establish procedures and best practices optimally utilizing our Regulatory Affairs talent.
-Leads regulatory-related education efforts and mentoring in areas of expertise.
-Supports Quality System (incl. CAPA activities) and audit readiness through data maintenance and compliance checks of functional 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.  
-Drives an overall customer centric and collaborative culture.
 
Required Qualifications:

-Minimum of a Bachelor’s degree or equivalent work experience
-Minimum of 7 years’ experience working under a medical device quality system
-Minimum of 2 years’ managing direct reports 
-Excellent written and oral communication
-Excellent research and analytical skills
-Ability to manage multiple projects simultaneously 
-Proven leadership, 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
-History of participating in process improvement initiatives
-Experience with audits from government bodies (e.g., EU AR, EU Competent Authority, MDSAP, ISO 13485)
-Ability to read and interpret regulations and standards
-Working knowledge of MDR and EUDAMED

Requisition ID: 563699

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 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 and look forward to connecting with you!

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