Senior Regulatory Affairs Specialist

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.

About the role:

At Boston Scientific, you'll discover a place where you can have meaningful purpose-improving lives through your life's work. In Rhythm Management (RM), we offer diagnostic and treatment solutions for irregular heart rhythms and heart failure, and protection against sudden cardiac arrest. We continue to innovate in key areas, extending our products into new geographies and high-growth adjacency markets.

Under minimal supervision, theSenior Regulatory Affairs Specialist will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and other global regulatory agencies. This individual ensures continued compliance with regulatory approvals by evaluating the impact of product and process changes. The role plays a critical part in supporting product development, global registrations, and market access efforts.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local 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. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

* Coordinate, compile, and submit U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations.
* Develop and execute domestic and international regulatory strategies for product approvals.
* Maintain positive relationships with regulatory reviewers through proactive verbal and written communications.
* Assess product and process changes for regulatory impact and ensure compliance with applicable regulations.
* Represent Regulatory Affairs on cross-functional product development and clinical project teams, providing regulatory guidance throughout the product lifecycle.
* Review and approve technical documentation and labeling for inclusion in regulatory submissions.
* Participate in cross-functional initiatives, including process improvements and change management projects.

Qualifications:

Required qualifications:

* Minimum of a Bachelor's degree or equivalent work experience.
* Minimum of 4 years' experience in regulatory affairs or related disciplines within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Post-Market Surveillance).
* Demonstrated proficiency with U.S. and international regulatory requirements for medical devices, including Quality Systems standards and clinical investigations.
* Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Preferred qualifications:

* Bachelor's degree in life sciences, engineering, computer science, or a related field.
* Previous experience with Class II or III medical devices.
* Prior experience interacting directly with the FDA, notified bodies, or international regulatory authorities.
* Regulatory experience with software as a medical device (SaMD).
* Strong written and verbal communication skills with the ability to convey complex ideas clearly.
* Solid technical, research, and problem-solving abilities.
* Proven ability to manage multiple projects and priorities effectively.
* Strong interpersonal skills and a collaborative mindset.

Requisition ID:619644

Minimum Salary: $82600

Maximum Salary: $156900

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.