Manager I, Regulatory Affairs Job

Company Name: Boston Scientific

Location: Maple Grove, MN, US - 55311

Job Duration: 2021-07-22 to 2021-08-21

Overview

Additional Locations:

 

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life’s work.

In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.

 

In this role, you will be responsible for a product line, technology, and specialized function. In addition, you’ll devote a portion of time to managerial, leadership, and employee development responsibilities. 
 
Your responsibilities will include:
•    Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization 
•    Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
•    Demonstrate ability to effectively manage multiple projects/establishing project priorities and priorities in a timeline driven environment (multiple line-down, NPD, 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.
•    Assists with developing and implementing departmental policy and procedure.
•    Provides Regulatory Affairs training/mentoring to other 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.
•    Implements regulatory strategies for new and modified products.
•    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.
•    Reviews and signs-off product and manufacturing changes for compliance with applicable regulations.
•    Provides oversight to core team members on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
•    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.
•    Lead a group or team of employees in the achievement of organizational goals. 
 
What we’re looking for in you:

 

Required Qualifications: 
•    A minimum of a Bachelor’s degree in scientific, technical or related discipline 
•    A minimum of 8 years experience in Regulatory Affairs required. 
•    Experience in Medical Device is also required
•    Demonstrated success in management of regulatory submissions activities including FDA (class lll/PMA) and CE Mark experience 
•    Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations 
•    Thorough understanding of product development process and design control.
•    Ability to effectively partner cross-functionally to develop and influence sound product strategies 
•    Solid technical knowledge of medical products and understating of relevant procedures, practices, and associated medical terminology 
•    Excellent research and analytical skills 
•    Ability to manage multiple projects simultaneously 
•    Excellent written and oral communication, technical writing and editing skills 
•    Solid leadership, interpersonal and influencing skills 
•    Ability to work independently with minimal supervision 

Preferred Qualifications: 
•    Professional certification(s) (ie RAPS, PMP….) 
•    Management experience highly preferred
•    International submission support (PMDA, CFDA, ANVISA, Health Canada, TGA, etc.) 

 

Requisition ID: 489973

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.