Global Regulatory Affairs Specialist

Boston Scientific; Marlboro (MA); Hybrid; USD 75,000 - 143,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Regulatory Affairs professional to support submissions and regulatory compliance across the development lifecycle. You will mentor teams, develop regulatory strategies for medical devices and coordinate with OEM/contract manufacturers to ensure registrations in the U.S., EU, China and beyond.

The role requires collaboration across manufacturing and development, preparation of global applications, and continuous quality improvements in line with our Quality Policy.

Qualifications

• Bachelor's degree in a scientific, technical or related discipline.
• Minimum of 2 years' Regulatory Affairs experience in the medical device industry.
• Experience with 510(k) submissions, EU MDR and international regulatory registrations.
• Working knowledge of FDA, EU and international regulations for medical devices.
• Ability to read and interpret global regulations and standards.
• General understanding of the product development process, design controls and quality system regulations.
• General understanding of regulations applicable to the conduct of clinical trials.

Responsibilities

• Provide technical guidance and regulatory training and mentoring to Regulatory Affairs employees and cross-functional teams.
• Assist with developing and implementing regulatory strategies for new and modified medical devices, as well as OEM and contract manufacturer partnerships.
• Serve as a liaison for new business partners, providing regulatory guidance for U.S., EU, China and international product registrations.
• Act as a core member of manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare and submit global regulatory applications and maintain internal regulatory file documentation.
• Review and approve product and manufacturing changes for compliance with applicable regulations.
• Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy.
• Continuously assess opportunities to improve quality.
• Develop and implement departmental and divisional policies and procedures.
• Support highly technical or major business-segment product lines, special projects and strategic initiatives.
• Review device labeling and advertising materials for compliance with global regulations and analyze and recommend appropriate changes.

Skills

Regulatory affairs

FDA submissions

EU MDR

Cross-functional collaboration

Project management

MS Office

Clinical trials

Education

Bachelor's degree

Job description

Boston Scientific is seeking a Regulatory Affairs professional to support submissions and regulatory compliance across the development lifecycle. You will mentor teams, develop regulatory strategies for medical devices and coordinate with OEM/contract manufacturers to ensure registrations in the U.S., EU, China and beyond.

The role requires collaboration across manufacturing and development, preparation of global applications, and continuous quality improvements in line with our Quality Policy.