Manager I, Urology/Pelvic Health, Regulatory Affairs Job

Additional Locations: US-MN-Minnetonka; US-MA-Marlborough; US-MN-Arden Hills

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.

About the role:

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 unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders.

This role within the Prosthetic Urology franchise will be responsible for existing product lines, involved in development and new technologies, including active implantables, Value Improvement and CAPAs including managerial, leadership, and employee development responsibilities.

Your responsibilities include:

* Directs and coordinates activities of Regulatory Affairs employees.
* Assists in establishing project priorities, allocating resources and workloads
* Provides technical guidance to 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.
* Provides short-range strategy formulation.
* Implements regulatory strategies for new and modified products including implants, combination products and the development of active implantables.
* Assists with developing and implementing departmental best regulatory practices.
* 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/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 documentation.
* 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 labeling.
* Reviews and signs-off product and manufacturing changes for compliance with applicable regulations.
* Provides CAPA support to regulatory team as well as cross-functional partners.
* 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.

Management Requirements:

* Lead a group or team of employees in the achievement of organizational goals.
* Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
* Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
* Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
* Participate and provide regulatory guidance on management teams.

What we're looking for:

Basic Qualifications

* Bachelor's degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
* 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 development teams
* Submission experience for active implantable and drug/device combination products preferred (FDA, PMDA, CFDA, ANVISA, Health Canada, TGA, etc.)
* Experience supporting manufacturing/operations 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
* Ability to manage multiple projects simultaneously
* Excellent written and oral communication, technical writing and editing skills
* Strong leadership, interpersonal and influencing skills
* Ability to work independently with minimal supervision
* Ability to collaborate with cross-functional partners/teams

About us

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: 483536