Manager I, Urology/Pelvic Health, Regulatory Affairs Job Date:
Jul 20, 2020
Location: Minnetonka, MN, US, 55343
Additional Locations: (n/a); US-MA-Marlborough;
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.
At Boston Scientific, our products and technologies are used to
diagnose or treat a wide range of medical conditions. We continue
to innovate in key areas and are extending our innovations into new
geographies and high-growth adjacency markets. The Urology and
Pelvic Health business of Boston Scientific includes Men’s Health
franchise for treatment of urologic conditions, including male
stress urinary incontinence and erectile dysfunction.
Responsible for product lines, technology including active
implantable, Value Improvement and CAPAs including managerial,
leadership, and employee development responsibilities.
Directs and coordinates activities of Regulatory Affairs
Assists in establishing project priorities, allocating resources
Provides technical guidance to team during the course of
submission preparation and interaction with regulatory bodies.
Supports Regulatory Affairs employees and cross functional team
in manufacturing site transfers with FDA, EU and International.
Reviews, edits and enhances submissions prepared by team
Represents Regulatory Affairs at management weekly/quarterly
updates by providing regulatory direction on successful
Provides strategy formulation during initial and long-term
Implements regulatory strategies for new and modified products
including the development of active implantables.
Actively involved in departmental best regulatory practices
providing support to team as needed.
Provides Regulatory Affairs training/mentoring to employees.
Assists with developing and maintaining positive relationships
with global device reviewers through oral and written
communications regarding pre-submission strategy/clinical and
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
Oversees review of device labeling and advertising materials for
compliance with submissions and applicable regulations; analyzes
and recommends appropriate changes.
Assists in the development of physician and patient
Reviews and signs-off product and manufacturing changes for
compliance with applicable regulations.
Provides CAPA support to regulatory team as well as
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
Fosters efforts to continuously improve department and
divisional quality, including collaboration, best practices, and
Lead a group or team of employees in the achievement of
Guide, coach, direct, and develop direct reports, and if
applicable, drive those practices throughout their
Foster a diverse workplace that enables all participants to
contribute to their full potential in pursuit of organizational
Monitor and ensure compliance with company policies and
procedures (e.g. federal/country and regulatory requirements).
Participate and provide regulatory guidance on management
Bachelor’s degree preferably in a scientific, technical
discipline or project management, Professional certification(s)
8+ years Regulatory Affairs or related field, Medical Device
experience required. International experience preferred
Management experience preferred
Demonstrated success in management of regulatory submissions
activities including FDA and Notified Body experience
Demonstrated success as the RA lead on large cross-functional
Submission experience for active implantable and drug/device
combination products preferred (FDA, PMDA, CFDA, ANVISA, Health
Canada, TGA, etc.)
Experience with FDA Case For Quality a plus, but not
Experience supporting manufacturing/operations driven projects
and achieving change approvals globally per business
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
Excellent research and analytical skills
Ability to manage multiple projects simultaneously
Excellent written and oral communication, technical writing and
Strong leadership, interpersonal and influencing skills
Ability to work independently with minimal supervision
Ability to collaborate with cross-functional partners/teams
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: 466507
Nearest Major Market: Minneapolis
Job Segment: Medical, Regulatory Affairs, Law, CAPA, Product
Development, Healthcare, Legal, Management, Research