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Regulatory Affairs Specialist II
2 months ago
Recruiter: Lydea Monahan
Regulatory Affairs Specialist II – Neuromodulation
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.
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.
- Other duties as assigned.
Required qualifications:
- 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
- Works well in fast-paced cross-functional team environments
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 [$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. 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: 586292
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
