Volt Little Canada , MN 55117
Posted 3 weeks ago
Volt is immediately hiring a Remote Medical Regulatory Affairs Specialist in Maplewood, MN with a well-known industry leader. As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world
This is a first shift position.
As a Regulatory Affairs Specialist, you will:
Lead/coordinate medical device and cosmetic regulatory affairs for part of the US designed portfolio
Coordinate communication and compliance globally
Support international requests
Support new product introductions and existing product changes
Partner to determine global regulatory strategy
Participate in audits; champion compliance
Support product licenses, establishment licenses, etc
Ensure market access and right to operate
Estimated Duration 24 months.
The ideal candidate will have:
Bachelor's degree or higher from an accredited institution.
Additional qualifications that could help you succeed even further in this role include:
Advanced Degree
Regulatory Affairs Certificate (RAC)
Medical Device Regulatory Affairs experience with FDA
EU MDR experience
Regulatory operations experience and process/systems understanding
International regulatory experience
Ability to interface with regulatory agencies and support audits
Proficient in Microsoft Office Tools
:
Pay Rate: $38.00-39.00 hr.
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 click here 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. § 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.
Volt