24 Months Contract to Direct Monday - Friday Hybrid Overview Review medical device complaints, determine MDR and Vigilance reporting requirements, and support regulatory report submissions. Responsibilities Review and document incoming complaint information. Evaluate complaints for MDR and Vigilance reporting. Prepare and submit required regulatory reports. Follow up with the field and internal teams for additional complaint information. Support complaint closure and timely review of investigations and follow-up actions. Ensure compliance with FDA and international regulatory requirements. Requirements Bachelor's degree required. Strong computer skills, including Microsoft Office. Background in healthcare, medical device, pharmaceutical, safety, or clinical data evaluation. Strong communication and attention to detail. Preferred Previous MDR or Vigilance experience. Nursing or other healthcare professional experience. Medical device industry experience. Degree in healthcare, science, or biomedical engineering. Knowledge of basic anatomy and physiology. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPB Pay:

$25.00 - $29.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

Hybrid remote in Saint Paul, MN 55112