- Act as company representative under minimal supervision, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, and submission review
- Research, develop, and implement regulatory strategies for new and modified medical devices
- Represent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cycle
- Prepare and submit regulatory documentation and applications
- Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
- Review and approve product and manufacturing changes for compliance with regulatory requirements
- Support and maintain Quality initiatives in accordance with BSC Quality Policy
- Continuously assess ways to improve Quality
- A minimum of a bachelor's degree in a scientific, technical, or related discipline
- A minimum of 5 years' Regulatory Affairs, or related experience (Quality, Clinical, R&D, Biocompatibility, etc.), within the medical device, pharmaceutical, or health care industry
- Working knowledge of US, EU, and/or international regulations for medical devices
- General understanding of product development process and design control
- General understanding of regulations applicable to the conduct of clinical trial
- Ability to manage several projects of moderate scope and complexity simultaneously
- Proficiency with Microsoft Office
- Effective research, analytical, and problem-solving skills
- Effective written and oral communication, technical writing, and editing skills
- Ability to work independently with minimal supervision
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Sr. Regulatory Affairs Specialist - Marlborough, United States - Boston Scientific
Description
Recruiter: Spencer Gregory HaleSr. Regulatory Affairs Specialist - Endoscopy
About the role:
Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust product portfolio provides a variety of solutions including but not limited to balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, radio frequency ablation, and enteral feeding. We continue to innovate and make investments in Endoscopy treatments, both within established product lines as well as in future pipelines.
The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.
Your responsibilities will include:
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
