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Form of workJob Description
Summary: Seeking a Documentation Specialist with experience in Regulatory Affairs and the IVD industry for product transition support.
Job Requirements:
Bachelors degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
2 to 5 years experience in Regulatory Affairs or experience in QA, R&D, Manufacturing within the IVD industry.
Strong documentation and organizational skills
Excellent computer applications skills including prior ERP experience and able to perform basic statistical analysis.
Preferred Skills:
Experience with IVDR CE Marking
Prior experience with cross-functional collaboration
Job Responsibilities:
Provide regulatory support for products transitioning from IVDD to IVDR CE Marking
Collaborate with cross-functional groups to collect and coordinate information and regulatory documentation
Update IVDR Labeling Conversion Log
Assist in generating Change Requests for product labeling according to Labelling conversion plan
Communicate and assist in the notification process to all International Regional RAs
Ensure product restrictions are implemented as required
Perform other IVDR or regulatory related duties as required or assigned.
Pay: 29-39
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.
Pay Details: $29.00 to $39.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
