Senior Specialist, Urology, Reg Affairs

Boston Scientific   •  

Marlborough, MA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 113 days ago

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 gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids.

 Job Purpose:

Responsible for Regulatory Affairssupport of submissions and on going regulatory compliance for product development process.

  Key Responsibilities:

•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

•Supports Design History File/Labeling integration, reviewing for regulatory requirements and current standards.

•Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

•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.

•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.

•Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

•Develops and implements departmental and divisional policies and procedures.

•Supports highly technical or major business segment product lines, special projects or strategic initiatives.

•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.

 Qualifications:

•Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline, Master’s in Regulatory preferred

•5+ years Regulatory Affairsexperience, medical device experiencerequired

•Working knowledge of FDA and international regulations

•General understanding of product development process and design control

•General understanding of regulations applicable to the conduct of clinical trials

•Working knowledge of regulatory requirements for implantable and single use disposable devices

•Ability to manage several projects

•Proficiency with Microsoft Office

•Effective research and analytical skills

•Effective written and oral communication, technical writing and editing skills

•Ability to work independently with minimal supervision

•Ability to travel periodically to support project deliverables

 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: 422682