Boston Scientific Regulatory Affairs Specialist II 

United States, Minnesota, Maple Grove 

582220245

This Regulatory Affairs Specialist II role will provide regulatory support on a wide variety of Interventional Cardiology devices with a focus on supporting US and EU compliance activities. This includes US Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities, audit support, and general compliance requests. Additional activities can include new product introduction support, evaluation of post market design changes, as well as other responsibilities aligned with global medical device regulations and goals of the business.

This is a hybrid position (in office minimum three days per week) in Maple Grove, MN with flexibility to be in Galway, Ireland. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

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:

• A minimum of a bachelor’s degree in a scientific, technical, or related discipline
• At least 2 years of experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, with a minimum of 1 year specifically in a Regulatory Affairs role
• Introductory knowledge of FDA and EU regulations for medical devices
• Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat

Preferred qualifications:

• Working knowledge of FDA, EU, and international regulations for medical devices
• Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedules
• Effective research, analytical, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators
• Advanced computer skills to support submissions and communication or presentations both internally and externally (e.g., MS Word troubleshooting such as linkages/references, page numbers, Section building, Table of Contents, etc.)
• Quick learner, self-motivated, and independent worker with minimal supervision
• Works well in fast-paced cross-functional team environments

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.