Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

This Regulatory Affairs Specialist II role will provide regulatory support on a wide variety of Interventional Cardiology devices with a focus on supporting sustaining commercial products and US and EU submission activities. This is a hybrid position (in office minimum three days per week) in Maple Grove, MN.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your Responsibilities Will Include :

• Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle
• Act as company representative developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy / regulatory pathway development, requirements, and full submission review process
• Prepare and submit regulatory documentation and applications focused on compliance requirements
• Review and approve product and manufacturing changes, device labeling, and advertising materials for compliance with regulatory requirements
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Participate in development and implementation of departmental policies and procedures
• Continuously assess ways to improve Quality

Required Qualifications :

Preferred Qualifications :

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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!

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.