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Sr. Specialist, Regulatory Affairs - Urology/Pelvic Health Job

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Date: Nov 5, 2021

Location: Marlborough, MA, United States, 01752

Company: Boston Scientific

Additional Locations:

 

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.

 

 

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.  Additionally, we continue to invest in SpaceOAR™ Hydrogel to help minimize the potential side effects of radiation therapy.  Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

 

 

Job Purpose:


Responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects.

 

Key Responsibilities:


•    Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
•    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.
•    Develops and implements regulatory strategies for new and modified products.
•    Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for 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.
•    Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
•    Trains to departmental and divisional policies and procedures.
•    Supports highly technical or major business segment product lines, sterilization processes, special projects or strategic initiatives.
•    Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility. 
•    Fosters efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing

 

 
Required Qualifications:


•    A minimum of a Bachelor’s degree 
•    A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
•    Prior experience with regulatory submissions writing 
•    Basic understanding of product development process and design controls
•    Working knowledge of FDA, EU and international regulations
•    An understanding of standards, in particular the IEC 60601 series of standards as well as IEC 62304.
•    Ability to manage several projects simultaneously
•    Effective research and analytical skills
•    Excellent written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision
•    Strong interpersonal and influencing skills
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

 

Preferred Qualifications:


•    Bachelor’s degree in a scientific or technical discipline
•    Prior experience with submission writing, including PMA, 510(k), combination drug/device, implantable device, or active implantable device
•    General understanding of regulations applicable to the conduct of clinical trials
•    Experience with capital equipment, radio frequency, interoperability and usability engineering are a plus.

 

 

 

 

Requisition ID: 511575

 

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.

 


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