Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

This Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Interventional Cardiology devices, with a primary focus on U.S. and EU compliance activities. Responsibilities include support for U.S. Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities, audit support, and general compliance initiatives. The role may also include support for new product introductions, evaluation of post-market design changes, and process optimization effortsaligned with global medical device regulations and broader business objectives.

This is a hybrid position based in Maple Grove, MN (in office at least three days per week).

Your responsibilities will include :

• Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle
• Act as a company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategies, regulatory pathway development, and full submission review processes
• Prepare and submit regulatory documentation and applications focused on compliance requirements
• Review and approve product and manufacturing changes, device labeling, and advertising materials for regulatory compliance
• Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy
• Participate in the development and implementation of departmental policies and procedures
• Continuously assess ways to improve quality and compliance practices
• Provide internal and external audit preparation and support
• Support innovation within Regulatory Affairs by proposing process optimization and efficiency strategies

Qualifications :

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).