Job Information
Volt SAF Regulatory/Environmental Specialist II in Maplewood, Minnesota
Volt is immediately hiring a Remote-Spanish-Speaking-Medical Device Regulatory Affairs Specialist II with a well-known industry leader. In this role you will work specifically with the company's German based medical device division. You must be fluent in Spanish and English. 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 Spanish is required
: 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). 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. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email hr_dept@volt.com or call (866) 898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. ยง 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.