Senior Regulatory Affairs Specialist - Urology

Senior Regulatory Affairs Specialist - Urology

Work mode : Hybrid

Onsite Location(s) : Irvine, CA, US, 92602

Additional Location(s) : US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

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 Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures.

The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include :

• 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

Required qualifications :

Preferred qualifications :