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Manager I, Regulatory Affairs - Global RA Operations Job

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 Global
Onsite Location(s): 


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



Team Purpose: The Global Regulatory Affairs Operations is a strategic partner that delivers innovative, efficient and sustainable business and regulatory solutions for customers throughout the product lifecycle.
This role manages and provides leadership to specialists that support EU sterilization submissions and shared services related to change management, distribution controls and authentication. This role will also be responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support.    



Key Responsibilities

•    Directs and coordinates activities of Regulatory Affairs employees.
•    Heads centralized functional activities including change management, distribution controls, invoice reconciliation and authentication.
•    Assists in establishing project priorities, allocating resources and workload.
•    Provides technical guidance during the course of regulatory strategy, submission preparation and interaction with regulatory bodies. Including, reviewing and editing of submissions prepared by team members.
•    Provides technical guidance in the execution of distribution controls and change management processes, including decisions on howe to execute for unique situations
•    Supports Quality System and audit readiness through data maintenance and compliance checks of owned processes.
•    Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
•    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 or equivalent work experience
•    Minimum of 6 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) in the medical device, pharmaceutical, or health care industry
•    Prior experience leading and/or managing others
•    Working knowledge of FDA, EU and/or international medical device regulations
•    Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
•    Ability to read and interpret global regulations and standards
•    General understanding of product development process, design controls and quality system regulations
•    Proficiency with Microsoft Office applications (Teams, Word, Excel, Powerpoint)



Preferred Qualifications:

•    Degree or work experience in a scientific or technical discipline 
•    Excellent written and oral communication, technical writing and editing skills
•    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
•    Demonstrated success in management of regulatory submissions activities including FDA and Notified Body experience
•    Demonstrated success as the lead on large cross-functional teams
•    Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations
•    Ability to work independently with minimal supervision 
•    Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions) 





Requisition ID: 525344


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.

Job Segment: Medical, Operations Manager, Regulatory Affairs, Law, Healthcare, Operations, Legal

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