Boston Scientific Regulatory Affairs Manager - Core Cardiac Rhythm Management Sustaining 

United States, Minnesota 

322346156

About this role:

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. In Cardiac Rhythm Management (CRM), we design, develop, and produce technologies that monitor, support diagnosis, and treat irregular heart rhythms, heart failure and sudden cardiac arrest. We have a robust product portfolio and future pipeline, and we will continue to make an investment in new and improved interventional treatments. We innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. Here, you’ll discover a place where you can have meaningful purpose and improve patient’s lives through your daily work.

The Regulatory Affairs Manager role is focused on providing valued regulatory management support for activities within the Core CRM Sustaining Program. This role will represent the Regulatory Affairs function during cross-functional project meetings and fulfill a people management role with multiple Regulatory Affairs submission specialists as direct reports. Leadership of the team includes cross-functional coordination and influence to strategically align on Franchise goals and strategies, employee development, managing team resources to support franchise priorities, and supporting day-to-day regulatory activities and responsibilities.

This role may work onsite (4+ days/week) or hybrid (3 days/week) at the Arden Hills, MN site.

Your responsibilities will include:

• Oversite management of Core CRM Regulatory Affairs Sustaining Program activities
• Manage a multi-person submission team within a matrixed organization
• Be responsible for required device and accessory product change submission activities - FDA and EU MDR, EU Cert Renewals, US Annual Reports, e-Labeling, International submission support, along with required product release approvals (PRA)
• Assist in establishing project priorities, allocating resources, and managing workloads to achieve business goals
• Study and understand applicability of relevant guidance and regulations and support regulatory-related education efforts and mentoring in areas of expertise
• Provide leadership, regulatory expertise, and training to team members with daily activities, including product change assessments and regulatory submission activities
• Develop and utilize relationships, tools, processes, and other resources to assist in solving problems and gain efficiencies through Sustaining Program Portfolio initiatives
• Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 5 years’ experience working under a medical device quality system or a related discipline (e.g., Regulatory Affairs, Project Management, Quality Systems, R&D, Post Market, Operation Management)
• Working knowledge of FDA, EU and/or international medical device regulations or experience in similar regulated industry/environments
• Demonstrated success in the management or execution of regulatory submission activities, including IDE, PMA, and EU MDR CE marking
• Excellent research and analytical skills

Preferred Qualifications:

• Prior experience leading and/or managing others
• Proven leadership, collaboration and influencing skills
• Excellent written and oral communication
• Ability to manage multiple projects simultaneously
• Track record of working independently with minimal supervision
• Experience with working within R&D project core team as a function lead
• Experience with audits from government bodies (e.g., FDA, MDSAP, ISO 13485), or related activities
• General understanding of product development process, design controls and quality system regulations
• Experience working with Cardiac Rhythm Management products

Maximum Salary: $188,300

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.