Manager, Regulatory Affairs - Urology

bostonscientific•Marlborough, MA

1d•$106,800 - $202,900•Hybrid

About The Position

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. The Urology business unit provides proven, leading solutions to treat common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence, and pelvic floor disorders. This role within the Stone franchise will be responsible for supporting existing product lines, developing new technologies, driving value improvement initiatives, and managing CAPAs. The role also includes managerial and leadership responsibilities, with a focus on employee development and cross-functional collaboration. Work model, sponsorship: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

Bachelor’s degree, preferably in a scientific, technical, or project management discipline
Minimum of 7 years' experience in Regulatory Affairs or a related field within the medical device industry
Demonstrated success in managing regulatory submissions, including FDA and Notified Body experience
Demonstrated success serving as the Regulatory Affairs lead on large cross-functional development teams
Experience supporting manufacturing or operations-driven projects and achieving global change approvals
Submission experience for single-use, implantable, and medical electrical equipment products (e.g., FDA, PMDA, CFDA, ANVISA, Health Canada, TGA)
Strong technical knowledge of medical products
Deep understanding of the product development process and design control
Strong technical understanding of regulatory procedures and relevant medical terminology
Excellent research and analytical skills
Ability to manage multiple projects independently
Excellent written and oral communication, technical writing, and editing skills

Nice To Haves

Management experience
International regulatory experience
Strong leadership and interpersonal skills
Influencing and cross-functional collaboration skills
Ability to work independently with minimal supervision
Strategic thinking and ability to influence product direction

Responsibilities

Direct and coordinate activities of Regulatory Affairs employees.
Assist in establishing project priorities and allocating resources and workload.
Provide technical guidance to the team during submission preparation and regulatory interactions.
Review and edit submissions prepared by team members.
Represent Regulatory Affairs in management updates and discussions.
Develop and implement short-range regulatory strategy.
Execute regulatory strategies for new and modified products, including single-use devices, implants, and medical electrical equipment.
Drive departmental best practices for regulatory processes.
Deliver Regulatory Affairs training and mentoring to employees.
Develop and maintain positive relationships with regulatory reviewers through clear, effective communication.
Oversee preparation and submission of global regulatory applications and maintain internal regulatory documentation.
Review labeling and advertising materials for compliance and recommend necessary changes.
Assist in developing physician and patient labeling.
Review and sign off on product and manufacturing changes for regulatory compliance.
Provide CAPA support to the regulatory team and cross-functional partners.
Promote a continuous improvement environment that aligns with Boston Scientific’s Quality Policy and System.
Ensure employee training is documented and compliant with quality standards.
Lead a team in achieving organizational goals.
Guide, coach, direct, and develop direct reports; promote these practices across the organization.
Foster a diverse, inclusive environment that enables all team members to contribute fully.
Ensure compliance with company policies and applicable regulations.
Provide regulatory guidance on management teams.