Regulatory Affairs Specialist II
7 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will play a critical role in ensuring compliance with worldwide regulatory requirements and supporting the preparation of submissions to obtain various worldwide approvals to commercially distribute products.
Key Responsibilities- 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
- Other duties as assigned
- A minimum of a bachelor's degree and 1-3 years' work experience in regulatory affairs
- Prior experience with class III Medical Devices
- Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards
- Effective written and oral communication, technical writing and editing skills
- Interpersonal, communication and negotiating skills
- Works well in fast-paced cross-functional team environments
- RA certification (by Regulatory Affairs Professional Society)
Boston Scientific offers a competitive salary range of $69,000 to $112,750, 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.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating an inclusive workplace that reflects the diversity of our patients, customers, and communities. We are proud to be a leader in medical science and are committed to advancing science for life.
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