What are the responsibilities and job description for the SAF Regulatory/Environmental Specialist II position at Volt?
JOB DESCRIPTION
Volt is immediately hiring a Remote Medical Device Regulatory Affairs Specialist II with a well-known industry leader. In this role you will have the opportunity to participate in a global healthcare spin-off and act as a contributing member for one of the regulatory affairs teams at the division level.
This is a first shift position.
As a Regulatory Affairs Specialist II you will :
- Have a significant impact on country registrations and labeling changes that are needed for medical devices, and some drug products.
- Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy.
- Redline medical device labeling based on global requirements per label checklist, reviewing and approving final labeling in internal systems
- Update documentation in technical files related to new legal manufacturer name and address and routing documents for approval in company internal document database
- Field requests from global regulatory associates for registrations, locating and sending requested documentation to global team for in country submissions
Estimated Duration up to 24 months.
The ideal candidate will have :
- Bachelor’s Degree or higher from an accredited university in a technical field such as Biology, Chemistry, Pharmacology, Biochemistry, etc.
- 2-3 years in regulatory affairs in the medical device industry
- Direct experience authoring technical documentation
- Direct experience reviewing and approving product labels and instructions for use for medical devices
- Experience supporting international registrations
- Compliance document creation : Preparing necessary compliance documents.
- Product assessment : Evaluating products and labeling.
- Fluency in English and German would be an asset
Pay Rate : $39.69 hr.
Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Benefits : Volt offers benefits (based on eligibility) that include the following : health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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Salary : $40
