Regulatory specialist

Volt is immediately hiring a Remote-Regulatory Affairs Specialist , with a well-known industry leader.

The position will work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy.

This is a first shift position.

As a Regulatory Affairs Specialist you will be :

• Redlining medical device labeling based on global requirements per label checklist, reviewing and approving final labeling in internal systems
• Updating documentation in technical files related to new legal manufacturer name and address and routing documents for approval in company internal document database
• Fielding requests from global regulatory associates for registrations, locating and sending requested documentation to global team for in country submissions.

Estimated Duration 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

Pay Rate : $39.00-39.69 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).

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

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Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.

S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Volt is acting as an Employment Agency in relation to this vacancy.

Last updated : 2024-03-23