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Manager I, Urology/Pelvic Health, Regulatory Affairs Job

Company: Boston Scientific Gruppe
Location: Minnetonka
Posted on: September 13, 2020

Job Description:

Manager I, Urology/Pelvic Health, Regulatory Affairs Job Date: Jul 20, 2020

Location: Minnetonka, MN, US, 55343

Additional Locations: (n/a); US-MA-Marlborough; US-MN-Minnetonka

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.

Purpose Statement:

Responsible for product lines, technology including active implantable, Value Improvement and CAPAs including managerial, leadership, and employee development responsibilities.

Key Responsibilities:

Directs and coordinates activities of Regulatory Affairs employees.

Assists in establishing project priorities, allocating resources and workload.

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 members.

Represents Regulatory Affairs at management weekly/quarterly updates by providing regulatory direction on successful strategy.

Provides strategy formulation during initial and long-term project discussions.

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 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.

Fosters efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.

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.

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 with FDA Case For Quality a plus, but not required.

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

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

Keywords: Boston Scientific Gruppe, Minnetonka , Manager I, Urology/Pelvic Health, Regulatory Affairs Job, Other , Minnetonka, Minnesota

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