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Principal Specialist, 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): 

US

Additional Location(s): US-MN-Arden Hills; 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.

 

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 partners with other functions (specifically Supplier Quality, Material Controls and Design Controls) to bring forward process improvements and efficiencies in the Regulatory Affairs / Product Approvals space. This role will also be responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support.    

 

 

Key Responsibilities


As primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical and Electrical Equipment spaces, this position will have the following responsibilities:
•    Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for efficiencies. Then, initiate and lead projects to address needs.
•    Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams.
•    Author, revise and edit standard operating procedures and work instructions.
•    Lead assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed.
•    Represent function in audit settings by presenting regulatory processes and evidence of compliance.
•    Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions.

 

 

Required Qualifications:


•    Minimum of a Bachelor’s degree or equivalent work experience
•    Minimum of 5 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
•    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
•    Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions)

 


 

 

Requisition ID: 524321

 

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.


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