Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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.
This role can sit remotely.
Your responsibilities include:
- Prepare 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.
- Other duties as assigned.
What we’re looking for:
- BS in Scientific discipline/engineering required.
- 5+ years of experience in the area of worldwide regulatory affairs in Post Marketing Assessment (both submissions and compliance) at medical device industry.
- Class III Medical Device experience
- Knowledge and experience of U.S. FDA, Canada and EU regulations and standards.
- 7+ years of PMA
- Interpersonal, communication and negotiating skills.
- RA certification (by Regulatory Affairs Professional Society)
Requisition ID: 483116
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.