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Principal Specialist, Urology/Pelvic Health, Reg Affairs Job

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Date: Nov 19, 2020

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a); US-MA-Marlborough; US-MN-Minnetonka

 

 

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, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

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 in support of BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
•    Develops and implements departmental and divisional policies and procedures.
•    Assesses regulatory processes and proposes and implements improvements or best practices.
•    Leads efforts to improve collaboration, knowledge sharing, and best practices within the department and division.

 

Key Qualifications:
•    Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•    Professional certification(s) and/or Master’s degree preferred
•    8+ years Medical Device Regulatory Affairs experience, or 5+ years Medical Device Regulatory Affairs experience and 3+ years of experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) within medical device industry
•    Submission experience including PMA, 510(k), combination drug/device, implantable device, and/or active implantable device  
•    Thorough understanding of US, EU and international medical device regulations 
•    Thorough understanding of product development process and design controls
Other Qualifications:
•    Demonstrated excellent written and oral communication, technical writing and editing skills
•    Excellent research and analytical skills
•    Strong leadership, interpersonal and influencing skills
•    Demonstrated ability to manage multiple regulatory projects, as well as serve as regulatory lead on projects
•    Ability to work independently with minimal supervision, as well as mentor/guide others
•    Strong technical knowledge of medical devices, procedures, practices, and related terminology
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    Solid understanding of Program Management
•    Experience with acquisitions and divestitures preferred
•    Proficient understanding of regulations applicable to conduct of clinical trials
•    Comprehensive understanding of medical device standards, in particular IEC 60601-series standards as well as IEC 62304
•    Experience with capital equipment, radio frequency, interoperability and usability engineering is strongly preferred
 

 

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 you’re looking to truly make a difference to people both around the world and around the corner, there’s 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

 

Requisition ID: 466593

 


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