Associate Director, Medical Device Safety Specialist

Takeda; Boston (MA); Remote; USD 153,000 - 242,000; Full time

Job summary

Join a leading company as an Associate Director, Medical Device Safety Specialist. This remote role involves ensuring compliance with medical device regulations, leading projects, and collaborating with various departments. Ideal candidates will have a Bachelor's degree in a health-related field and significant experience in device safety or quality assurance.

Qualifications

• At least 5 years’ experience in device safety or quality assurance.
• Knowledge of clinical trials, risk management, and compliance standards.

Responsibilities

• Ensure compliance with medical device regulations.
• Prepare and review regulatory documents.
• Lead projects and guide teams.

Skills

Communication

Leadership

Strategic Planning

Education

Bachelor’s Degree in a health-related field

Tools

Office tools

Argus

Trackwise

Job description

Associate Director, Medical Device Safety Specialist

Join us as an Associate Director, Medical Device Safety Specialist at Takeda in our Cambridge, MA office. This remote position supports activities related to the safety oversight of Takeda medical devices throughout their lifecycle, including compliance with safety reporting requirements, post-market surveillance, and risk management. The role involves collaboration with various departments such as Medical Safety, Clinical Development, Regulatory Affairs, and Quality Assurance.

Key Responsibilities:

• Ensure compliance with medical device regulations and legislations
• Prepare and review regulatory documents for internal use and authorities
• Develop and implement compliance and operational plans
• Lead projects and guide teams, communicating progress to leadership
• Monitor and interpret global and local regulatory developments impacting devices
• Serve as a subject matter expert and liaison with internal and external stakeholders
• Identify process improvements for ongoing compliance
• Work with case processing teams to resolve device safety issues
• Communicate project expectations effectively and build positive relationships

Qualifications:

• Bachelor’s Degree in a health-related field (Nursing, Biomedical Engineering preferred)
• At least 5 years’ experience in device safety or quality assurance within the pharmaceutical or CRO sectors
• Proficiency with Office tools and safety databases (Argus, Trackwise) a plus
• Knowledge of clinical trials, risk management, MedDRA language, and compliance standards (EU MDR, FDA CFR, ICH)
• Strong communication, leadership, and strategic planning skills

This position is classified as remote under Takeda’s hybrid and remote work policies. The salary range is $153,600 - $241,340 per year, dependent on experience and qualifications.