Develop and implement medical device regulatory strategies
Author and review global submissions
Provide technical review of data
The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations
Job Summary
The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations.
This position includes supporting internal and external customer regulatory requests.
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected.
Matching Summary
The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations.
Skills & Requirements
Must-have
Develop and implement medical device regulatory strategies
Author and review global submissions
Provide technical review of data
Support internal and external customer regulatory requests
Maintain working knowledge of computer software packages
Nice-to-have
Lifelong learning, growth and development
Inclusive community of professionals
Sustainability efforts
Key Requirements
Minimum 5 years of relevant experience
2+ years of medical device regulatory experience preferred
Experience with US FDA regulations
Experience with EU MDD and EU MDR
History of successful international device registration