Specialist I, Reg Affairs

 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview. 

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 global team members in all Divisions / Regions to support product approvals & maintenance via execution of change communication and implementation activities, among other continuous improvement initiatives.

Key Responsibilities:

Support process and sub-process stewards and process owners for global regulatory processes. Responsibilities include the following:

• Support execution of change communication and distribution control processes for all divisions and regions
• Support data analysis in Global Regulatory Operations functions
• Collaborate with division and country regulatory affairs to gather information related to continued improvement of global regulatory processes
• Support regulatory standard operating procedures and work instructions through project support
• Support CAPA and NCEP correction and solution activities

Required Qualifications:

• Minimum of a Bachelor’s degree or equivalent work experience, 
• 0-2 years’ of 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

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 in English
• Excellent skills in supporting internal customers
• Excellent analytical skills in problem / contextual investigation
• 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
• General understanding of product development process, design controls and quality system regulations
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint). Advanced proficiency in Excel highly desired
• Proficiency in basic data analytics, including Power BI or similar tools

Requisition ID: 591920

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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.