Regulatory Affairs Specialist II

Work mode: Hybrid

Onsite Location(s):

Arden Hills, MN, US, 55112

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

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.

Regulatory Affairs Specialist II
Cardiac Rhythm Management (CRM) Division – Arden Hills, MN

About the role:

As part of Boston Scientific’s Cardiac Rhythm Management (CRM) division, you will contribute to delivering advanced, life-saving and sustaining technologies to patients worldwide. Our innovative solutions diagnose and treat a range of heart conditions—and we continue to expand into new markets with a focus on impactful, emerging technologies.

In this role, you’ll support global regulatory submissions and compliance efforts, working across Class I, II, and III medical devices as well as drug/device combination products. As a Regulatory Affairs Specialist II, you’ll be encouraged to stay curious, apply critical thinking, and grow your knowledge across technologies and regulatory systems. You’ll join a high-impact team delivering transformative cardiac therapies to patients across the globe.

Work model, sponsorship:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Arden Hills, MN office at least three days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

● Support development of global regulatory strategies for Class I, II, and III medical devices and drug/device combination products
● Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products—including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, annual reports, and CE Mark submissions under MDR
● Assist with international regulatory requests related to submissions, registrations, and change assessments
● Review product and manufacturing changes for regulatory compliance and filing impact
● Support regulatory audits as required
● Review promotional materials for regulatory compliance
● Represent Regulatory Affairs on cross-functional projects involving product development, manufacturing changes, and process improvement initiatives
● Support departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations activities
● Collaborate with Clinical Affairs on aspects of clinical trials and clinical report development
● Stay informed on emerging technologies and assess their regulatory and organizational implications

Required qualifications:

● Bachelor’s degree in life sciences, engineering, or a related discipline
● Minimum of 2 years' experience in Regulatory Affairs or a related field
● Strong technical writing skills

Preferred qualifications:

● Working knowledge of regulatory requirements for medical devices and drug/device combination products
● Effective written and oral communication skills
● Proficiency with Microsoft Office and Adobe Acrobat
● Experience working on cross-functional teams
● Internship, work-study, or coursework involving U.S., EU, or international medical device regulations and quality systems
● Ability to work both independently and collaboratively, with appreciation for diverse perspectives
● Experience interacting with the FDA, Notified Bodies, or international regulatory authorities
● Demonstrated ability to manage multiple projects and shifting priorities

Requisition ID: 622783

Minimum Salary: $71500

Maximum Salary: $135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

Nearest Major Market: Minneapolis
Job Segment: Regulatory Affairs, Compliance, Medical Device, CRM, Technical Writer, Legal, Healthcare, Technology

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