Regulatory Affairs Specialist I

at  Boston Scientific Corporation

QUALIFICATIONS/ EXPERIENCE:

• Honours Bachelor’s Degree (level 8) in life sciences, engineering or related field
• Basic knowledge of FDA and international regulations
• Ability to communicate complex ideas clearly and simply both orally and in writing
• Basic understanding of medical device regulations, FDA and international regulations.
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• General understanding of product development process and design control
• Ability to work independently with minimal supervision
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
  Requisition ID: 592387
  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!
  Job Segment: Regulatory Affairs, Compliance, Medical Device, Testing, Law, Legal, Healthcare, Technolog

PURPOSE STATEMENT

The Regulatory Affairs Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and ensures continued compliance with regulatory agency approvals.

RESPONSIBILITIES WILL INCLUDE:

• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
• Review, assessment and sign-off on product and manufacturing changes in compliance with applicable regulations
• Provides technical guidance and regulatory training/mentoring to cross-functional teams.
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding 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 manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• 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.
• Ensures appropriate training is maintained to do the work and training is documented.