Specialist II, Regulatory Affairs, Urology & Pelvic Health Job

Company Name: Boston Scientific

Location: Marlborough, MA, US - 01752

Job Duration: 2022-01-14 to 2022-02-13

Overview

 

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – 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: 

 

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. These conditions account for 50 percent of all urology surgical procedures.  Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

 

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.  The Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory submissions to EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

 

Your responsibilities will include: 

 

You will be responsible for Regulatory Affairs support of EU Medical Device Regulations (MDR) submissions and on-going regulatory compliance for product development process and sustaining engineering projects.

•    Reviews and collaborates with design, clinical, and manufacturing teams on responses to questions from EU regulatory bodies related to compliance to the EU Medical Device Regulation (MDR).
•    Acts as company representative, 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 by Notified Body and other regulatory authorities.
•    Develops and implements regulatory strategies for new and modified products.
•    Acts as a core member on teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions, especially EU MDR submissions.
•    Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
•    Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation with particular emphasis on MDR documentation.
•    Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes with particular emphasis on MDR documentation.
•    Trains to departmental and divisional policies and procedures.
•    Fosters a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
•    Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.
 

 

What we’re looking for in you: 

 

Required Qualifications: 

•    Minimum of a Bachelor’s degree or equivalent work experience,
•    Minimum of 3 years of experience in Regulatory Affairs, or a related discipline in medical devices such as R&D, Quality, Clinical, Medical Affairs, or Biocompatibility
•    General understanding of product development process and design controls
•    Ability to manage several projects simultaneously
•    Working knowledge of FDA, EU and international regulations
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    Effective research and analytical skills
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision

 

Preferred Qualifications: 

•    Bachelor’s degree in a scientific or technical discipline
•    Prior experience with EU MDR assessments and/or submissions.
•    General understanding of regulations applicable to the conduct of clinical trials

 

 

 

Requisition ID: 517787

 

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.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.