Life Science Staffing
Sr Regulatory Affairs Specialist
Life Science Staffing, Adairsville, Georgia, United States, 30103
The Regulatory Affairs Specialist is responsible for preparation of submissions with a primary focus on EU/MDR, along with supporting all other regions registrations.
Responsibilities: Regulatory support for product life cycle on product teams Prepare STED technical files Offer support and guidance for post market activities Prepare and support 510(k)
Education / Experience:
BS degree 4 years' experience in regulatory position in the medical device space Experience with regulatory for EU/MDR and Article 120. Experience making changes to technical files. Ability to travel internationally up to 15% is required. Experience with Class II or III medical devices.
Responsibilities: Regulatory support for product life cycle on product teams Prepare STED technical files Offer support and guidance for post market activities Prepare and support 510(k)
Education / Experience:
BS degree 4 years' experience in regulatory position in the medical device space Experience with regulatory for EU/MDR and Article 120. Experience making changes to technical files. Ability to travel internationally up to 15% is required. Experience with Class II or III medical devices.