Senior Regulatory Affairs Specialist

Additional Location(s):  N/A

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 division provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male and female 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! Learn more about our Urology division here: https://www.linkedin.com/showcase/bsc-uroph/

 
Your responsibilities will include:

• Acting as company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up of submissions under review
• Developing and implementing regulatory strategies for new and modified products
• Acting as a core member on sustaining and new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
• Reviewing and approving design and manufacturing changes for existing products, ensuring compliance with applicable regulations and standard requirements
• Reviewing, providing input, and approving advertising and promotional materials, as needed
• Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation
• Reviewing device labeling and advertising materials for compliance with global regulations and standard requirements; analyzes and recommends appropriate changes
• Solving or proposing solutions to a range of problems of varying scope and complexity through applying technical and/or functional experience or existing solutions
• Logically presents information to convey key messages and complex information to others
• Training to departmental and divisional policies and procedures
• May lead small projects or represent Urology Regulatory Affairs on corporate teams, as needed
• Fostering a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
• Supporting efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing

 

Required qualifications:

• Bachelor’s degree 
• 3+ years of experience in Regulatory Affairs or related experiences
• Understanding of regulations applicable to medical devices
• Demonstrated proficiency of FDA, EU and/or international regulations 
• Up to 10% travel

 
Preferred qualifications:

• Master’s Degree in a business, scientific or technical discipline
• Demonstrated proficiency in understanding product development process and design controls
• Experience with supporting implantable devices from a regulatory perspective
• Understanding of regulations applicable to the conduct of clinical trials
• Ability to manage several projects simultaneously
• 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

 

Requisition ID: 590670

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.