Additional Location(s): US-CA-Valencia; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove
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:
Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements. Responsible for Regulatory Affairs support for the product development process, submissions and regulatory compliance.
Your responsibilities include:
- Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products
- In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries.
- Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies.
- Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals.
- Support product registrations for international markets as required.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Acts as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
- Assists with departmental policy and procedure implementation.
- Assists with Regulatory Affairs training to cross functional groups.
- Implements regulatory strategies for new and modified medical devices.
- Acts as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
- Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
- Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
Required qualifications:
- A minimum of a bachelor’s degree or equivalent work experience
- A minimum of 5 years work experience in regulatory affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
- Prior experience with class III Medical Devices
- Knowledge and experience with U.S. FDA, EU, and/or international regulations and standards.
Preferred qualifications:
- Minimum of 7 years experience with Post Market Assessment
- Interpersonal, communication and negotiating skills.
- RA certification (by Regulatory Affairs Professional Society)
The anticipated annualized base pay range this full-time position working at this location will be from [$81,900 to $155,600], plus variable compensation, i.e., annual bonus target (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at www.bscbenefitsconnect.com. At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. BSC considers various factors in determining actual compensation for this position at the expected location. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.
Requisition ID: 569539
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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.