• Manager I , Urology Mens Health , Regulatory Affairs Jobs in United States Of America - 25367534

  • United States Of America, Usa
  • Save Job
  • 8 - 11 Years
  • Posted : above 1 month

Job Description:

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, were solving some of the most important healthcare industry challenges Together, were one global team committed to making a difference in peoples lives around the world This is a place where you can find a career with meaningful purposeimproving lives through your lifes 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 Mens Health and Prostate Health for treatment of urologic conditions, including benign prostatic hyperplasia (BPH), 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
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 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 BSCs 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 (eg federal/country and regulatory requirements)
Participate and provide regulatory guidance on management teams


Bachelors 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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : HR/PM/IR/Training
Role : Recruitment
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

Taking these free online tutorials can help you get your next job

People who search this job also searched for the following Keywords

All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status