What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at ProKatchers LLC?
Job Title : Senior Regulatory Affairs Specialist
Location : Chaska, MN 55318
Duration : 12 Months
Shift Details : Onsite
Specific Skills :
Regulatory Affairs / Data Analysis / Global Regulatory Compliance
Skills:
- The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on the organization’s regulatory programs.
- The incumbent’s primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.
- Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
- Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
- Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
- Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
- Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.
Qualifications:
- Bachelor’s degree in field with 5 years exp. OR Master’s degree in field with3 years exp.
Medical Technologist background and IVD experience strongly desired