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Principal Specialist, Global Regulatory Affairs Operations Labeling SME

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:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Arden Hills; US-IN-Spencer; US-MA-Marlborough; US-MN-Maple Grove; US-MN-Minnetonka

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: 

 

At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work. Global Regulatory Affairs (RA) Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment.

 

This Regulatory position will be responsible for meeting the Regulatory Affairs goals and directions regarding labeling compliance for all international markets outside of the USA where BSC conducts business.

 

 

Your responsibilities include:

 

Participate as the Regulatory Core Team member as the Voice of Regulatory on process improvements within the Labeling Configuration and Lifecycle Management (LCLM) and Localization Process overhaul projects including LitDx, eLabeling, Postponement, Labeling Change Analysis, and Product Release. This includes gaining RA stakeholder alignment, change management for the Regulatory function, and advocating for the Regulatory function.
Monitor and capture new (or modified) labeling requirements in OUS (outside of USA) markets; work with Country RA to process the new or modified requirements through the regulatory requirements process
Partner with countries, GLOBE / localization team, and distribution centers to develop and maintain processes to meet country localization requirements. Activities may include procedure development, document approval, continuous improvement exercises and project management.
Escalate issues where country requirements may not be able to met by current process and partner with Division (BU) labeling, GLOBE / localization team, and cross-functional teams to create a solution to meet the country requirements.
Actively participate as a member of the labeling intake board
Provide guidance, consultation, and recommendations to divisional teams regarding labeling changes and impact to countries

 


Required Qualifications:

 

•Minimum of a Bachelor’s degree in communication, science, or engineering, or the equivalent years of work experience
•Minimum of 5 years’ experience in Regulatory Affairs or Labeling, or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
•Minimum of years’ experience in Systems/Applications as Product Owner or SME
•Experience with managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization.
•Excellent communication skills, with ability to transfer knowledge efficiently.
•Demonstrated high degree of integrity, professionalism, and the ability to establish credibility.
•Strong technical, research and problem-solving skills
•Strong computer, word processing and database skills

 

 

Preferred Qualifications:


•Ability to establish, communicate and engage teams in the vision & strategy of the program
•Ability to create a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding and celebrating superior performance, and creating an inclusive workplace across multiple locations.
•High sense of urgency and commitment to execution.
•Willingness to travel to divisions, regions, and corporate headquarters (estimate 15% travel in non-pandemic conditions)

 


 

 

Requisition ID: 545250

 

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Pharmaceutical, Operations Manager, Medical Device, Legal, Science, Operations, Healthcare

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