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Specialist II, Reg Affairs 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 in Country
Onsite Location(s): 

US

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

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 internal customers throughout the product lifecycle. This role partners with other functions to bring forward process improvements and efficiencies in the Regulatory Affairs / Product Approvals space.    

 

Key Responsibilities


Support process and sub-process stewards and process owners for global regulatory processes, responsibilities include the following:


•    Collaborate with division and country regulatory affairs to gather information related to filling process gaps and supporting value improvement projects .
•    Support regulatory standard operating procedures and work instructions.
•    Support assessments for global requirement changes and collaborate with cross-functional partners on changes to the quality system as needed.
•    Support CAPA and NCEP correction and solution activities.
•    Support regulatory strategy and execution 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 2 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, pharmaceutical industry, or health care industry
•    Working knowledge of FDA, EU and/or international medical device regulations
•    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:


•    Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
•    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 support multiple projects simultaneously

 


 

 

Requisition ID: 522178

 

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: CSR, PLM, CAPA, Compliance, Regulatory Affairs, Management, Legal

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