Senior Regulatory Affairs Specialist - Urology job at Boston Scientific, responsible for regulatory support, compliance, and product development. The role requires a minimum of 5 years of experience in Regulatory Affairs or a related field.
Requirements
- Develops and implements regulatory strategies for new and modified products.
- Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
- 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
- Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
- Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
- Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
- Reviews device labeling 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 such as combination products, sterilization processes and other special projects or strategic initiatives
- Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
Benefits
- 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.
