Regulatory Affairs Specialist II

Additional Location(s):  N/A

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 this role: 

As a part of the Boston Scientific Cardiac Rhythm Management division, you will work to deliver advanced, life-saving and sustaining technologies to patients worldwide.  We provide innovative solutions for diagnosing and treating heart conditions, and we’re constantly advancing in crucial areas and expanding our reach into new markets and regions.

Under supervision, the Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory to the US FDA and EU notified bodies, while supporting global product registrations and change impact reviews to ensure continued compliance with regulatory agency approvals. 

In this role, you will be encouraged to be curious, develop and employ creative and critical thinking skills, and will have the opportunity to satisfy your desire to learn about emerging technologies and their impact on the business and organization. Joining the Cardiac Rhythm Management (CRM) Regulatory team at Boston Scientific means you’ll play a pivotal role in delivering cutting-edge technologies that preserve and save lives across the globe.

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

• Relocation is not available at this time for this position.

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

Your responsibilities will include: 

• Supporting the development of global strategies for regulatory approval of Class I, II and III medical devices
• Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR 
• Assisting with BSC International regulatory requests regarding submissions, registrations, and change assessments; develop and manage relationships with regulatory representatives 
• Reviewing product and manufacturing changes to ensure compliance with applicable regulations and impact on regulatory filings
• Supporting regulatory audits as needed
• Reviewing promotional materials for regulatory compliance
• Representing Regulatory Affairs on cross-functional projects such as product development, manufacturing process changes, and continuous improvement
• Assisting with departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations initiatives
• Keeping abreast of emerging technologies and potential business and organizational impacts
• Working with clinical affairs on various aspects of clinical trials and clinical reports

Required Qualifications

• Bachelor’s degree in life science, engineering or related disciplines

• 2+ years regulatory or related experience
• Technical writing skills 

Preferred Qualifications

• Working knowledge of regulatory requirements for medical devices
• Effective written and oral communication skills
• Strong computer skills with experience using Adobe Acrobat and Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Experience working with cross-functional teams
• Relevant coursework, work-study, or internship experience with US, EU, and international regulatory requirements for medical devices and quality systems standards
• Ability to work effectively as an individual and as part of a team; ability to recognize and consider varying perspectives
• Experience working directly with US FDA, notified bodies and/or international health authorities

• Demonstrated ability to effectively lead multiple projects and priorities

#LI-Hybrid

Requisition ID: 611584

Minimum Salary: $69500 

Maximum Salary: $132000 

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 identify, 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.