Apply on Employer Site

Boston Scientific · 1 day ago

Manager, Regulatory Affairs - Urology

Marlborough, MA

Full-time

Hybrid

Mid, Senior Level

$107K/yr - $203K/yr

7+ years exp

Boston Scientific is a leader in medical science, dedicated to solving important health industry challenges. The role of Manager, Regulatory Affairs for the Urology business unit involves overseeing regulatory affairs activities, managing a team, and ensuring compliance with regulatory standards while supporting product lines and developing new technologies.

Health CareMedicalMedical Device

No H1B

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

Qualification

Regulatory AffairsRegulatory submissionsMedical device industryTechnical writingProject managementCross-functional collaborationAnalytical skillsLeadership skillsCommunication skillsInterpersonal skillsStrategic thinking