Boston Scientific Regulatory Affairs Specialist III - Urology 

United States, California, Irvine 

760163472

We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you’ll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.

⦁ A minimum of a Bachelor’s Degree in a scientific, technical, or related discipline
⦁ A minimum of 4 years Regulatory Affairs experience in the medical industry
⦁ Prior experience with 510(k) submissions, EU MDR or international regulatory registrations
⦁ Prior experience with PMA submissions or Class III submissions
⦁ Prior experience with active implantable devices, active devices, or long-term implants.
⦁ Working knowledge of FDA, EU and international regulations for medical devices
⦁ General understanding of product development process, design control and quality system regulations
⦁ Ability to simultaneously manage several projects
⦁ Proficiency with Microsoft Office
⦁ Effective research and analytical skills
⦁ Effective written and oral communication, technical writing and editing skills
⦁ Ability to work independently with minimal supervision

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.