Additional Locations: US-MN-Maple Grove
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
Our regulatory team is focused on delivering world class performance by working strategically with our cross-functional partners to maintain and bring new products on the market that meet global regulatory requirements. We partner with regulatory agencies to gain support on innovative and creative regulatory pathways to accelerate product approvals. We support the Interventional Oncology franchise (IO) within the Peripheral Vascular Division providing cancer and non-cancer treatment options using minimally invasive procedures under image guidance. We help improve and save people’s lives through innovative medical devices and solutions.
The Peripheral Vascular Division is a growing division within Boston Scientific with strong leadership and future goals to provide category leadership within the arterial, venous and interventional oncology space. We promote a collaborative learning environment where ideas, technical expertise, knowledge and experiences are shared to facilitate high performance in us all. We value quality & integrity, innovation, strategic thinking, and collaboration. This is a great opportunity to gain franchise leadership exposure, manage the core IO portfolio of existing and new product development, and cultivate a high performing team. We are looking for someone with global regulatory experience in the US, EU, Japan, and China who demonstrates high regulatory strategy competencies and partners with regulatory agencies. We want someone who reinforces our core values and is focused on people development.
In this role, you will be responsible for product lines, technology, managerial, leadership, and people development activities.
- Directs and coordinates activities of Regulatory Affairs employees
- Provide development opportunities for employees
- Responsible for diverse product lines within the Interventional Oncology franchise including embolization microspheres, microcatheters, guidewires, ablation devices, embolization coils, drainage catheters / stents, etc
- Manage the transition of MDR compliance for Interventional Oncology medical devices
- Assists in establishing project priorities, allocating resources and workload
- Provides technical guidance to the team during the course of submission preparation and interaction with regulatory bodies
- Reviews and edits submissions prepared by team members
- Represents Regulatory Affairs at management updates
- Develops and overseas innovative regulatory strategies for new and modified products
- Assists with developing and implementing departmental policy and procedure.
- Provides Regulatory Affairs training/mentoring to employees
- Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
- Oversees preparation and submission of global regulatory applications as appropriate as well as internal regulatory file documentation.
- 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. Ensure employees are trained to do their work and their training is documented.
What we’re looking for in you:
- 10+ years Regulatory Affairs, Medical Device experience required. US, EU, and International regulatory experience preferred
- 3+ years experience in a people management role
- Bachelor’s degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
- Demonstrated success in management of regulatory submissions activities including FDA and Notified Body experience
- Demonstrated success as RA lead on large cross-functional development teams
- Excellent worldwide regulatory strategic planning skills
- Submission experience for drug/device combination products preferred (FDA, PMDA, CFDA, ANVISA, Health Canada, TGA, etc.)
- Experience supporting manufacturing/operations/acquisition driven projects and achieving change approvals globally per business expectations
- Strong understanding of product development process and ability to effectively partner cross-functionally to develop and influence sound product strategies
- Strong technical knowledge of medical products
- Strong technical understanding of relevant procedures, practices, and associated medical terminology
- Thorough knowledge of product development process and design control
- Excellent research and analytical skills
- Excellent people development skills
- Ability to manage multiple employees and projects simultaneously
- Excellent written and oral communication, technical writing and editing skills
- Strong leadership, interpersonal and influencing skills
- Ability to collaborate and build rapport with cross-functional partners, teams, and external regulatory agencies
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer - Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 452724