• Senior Manager , Peripheral Interventions , Regulatory Jobs in United States Of America - 25363726

  • BOSTON SCIENTIFIC
  • United States Of America, Usa
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

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, 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

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 peoples 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

Purpose

In this role, you will be responsible for product lines, technology, managerial, leadership, and people development activities

Responsibilities

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 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

What were 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
Bachelors 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

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 youre looking to truly make a difference to people both around the world and around the corner, theres 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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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