Global Regulatory Operations Specialist II

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.                

About the role: 
At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work.  The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report into the Manager responsible for cross divisional sterilization activities.

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, Maple Grove, or Minnetonka, MN or Marlborough, MA.  You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include: 

• Support sterilization process owner and global regulatory processes, responsibilities include the following:
• Support regulatory strategy to gain approval for Ethylene Oxide (EO) sterilization initiatives 
• Author and submit EU MDR and US submissions for EO sterilization changes
• Support and draft EU sterilization Notified Body (NB) questions and correspondence
• Regular interaction with all Sterilization Subject Matter Experts (SMEs), Global Regulatory Affairs Operations team members, sterilization project members, and periodically with Divisional and/or Country Regulatory Affairs representatives
• Own regulatory Standard Operating Procedures (SOPs) and Work Instructions (Wis) applicable to this role
• Operate effectively as regulatory team lead on assigned projects 
• Support global regulatory projects/initiatives as needed

Required Qualifications:

• 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 or health care industry

Preferred Qualifications:

• Degree or work experience in a scientific or technical discipline
• Experience with EO sterilization methods and processes
• Excellent written and oral communication, technical writing and editing skills
• Excellent research and analytical skills
• Ability to support multiple projects simultaneously
• Working knowledge of FDA, EU and/or international medical device regulations
• Ability to read and interpret global regulations and standards
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint) 

#LI-Hybrid

Requisition ID: 592375

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance 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.