Senior Regulatory Affairs Specialist Vascular Therapies

Maple Grove, MN - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Additional Location(s):US-MN-Maple Grove

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

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:
Join our Interventional Cardiology and Vascular Therapies team where we create innovative technologies to diagnose and treat peripheral vascular disease. Our productsincluding medical electrical equipment such as consoles catheters and other associated devicesimprove patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

The Senior Regulatory Affairs Specialist is responsible for planning managing and implementing regulatory submissions to the US FDA and EU notified bodies as well as supporting world-wide product registrations. This role also ensures ongoing compliance with regulatory agency approvals including change impact reviews.

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.

Your responsibilities will include:
Supporting the development of domestic and international strategies for Class II and III medical devices
Representing Regulatory Affairs on cross-functional projects including product development manufacturing process changes and continuous improvement efforts
Reviewing and approving design and manufacturing changes for existing products to ensure compliance with applicable regulations
Coordinating compiling and submitting U.S. and EU regulatory filings for new and modified products including PMAs PMA Supplements Pre-Submissions 510(k)s Annual Reports and CE Mark submissions under MDR
Supporting international geographies to gain and maintain product approvals
Driving continuous improvement in department and divisional quality practices collaboration and knowledge sharing
Supporting regulatory audits as required

Qualifications:

Required qualifications:
Bachelors degree in a relevant field
Minimum of 4 years experience in Regulatory Affairs or a related discipline in medical devices (e.g. R&D Quality Clinical Biocompatibility Labeling)
Demonstrated experience authoring or supporting a variety of regulatory submissions for the U.S. and EU including 510(k)s and MDR technical documentation
Proficiency in Microsoft Word Excel PowerPoint and Adobe Acrobat

Preferred qualifications:
Experience supporting medical electrical equipment including consoles
Experience with regulatory support for software and cybersecurity
General understanding of the product development process and design controls
Working knowledge of U.S. FDA EU and international medical device regulations
Ability to manage multiple projects simultaneously
Strong research analytical and problem-solving skills
Excellent written and verbal communication technical writing and editing skills
Ability to thrive in fast-paced cross-functional team environments
Team player with strong interpersonal skills

#LI-Hybrid

Requisition ID:621610

Minimum Salary: $85000

Maximum Salary: $161500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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) isnt just business its personal. And if youre 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 Companys policies or protocols change with regard to COVID-19 vaccination.

Required Experience:

Senior IC

Additional Location(s):US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most ...