Regulatory Affairs Specialist - Senior

Yoh Services, LLC
Sep 14, 2019
Job Type
Full Time
Regulatory Affairs Specialist needed for a contract opportunity with Yoh's client located in Chaska, MN.The Big Picture - Top Skills Should You Possess The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on regulatory programs. The incumbent's primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities. What You'll Be Doing Administration of the companies' complaint management program for compliance to corporate requirements 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. What You Need To Bring To The Table Bachelor's degree in field with five (5) plus years' experience OR Master's degree in field with three (3) plus years' experience Bonus Points! Otherwise Known As Preferred Qualifications: Medical Technologist background and IVD experience strongly desired. Opportunity is Calling, Apply Now!Recruiter: Angela HolsappleYoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.#ESNAP