Regulatory Affairs Specialist II

10 hours ago

Minneapolis, Minnesota, United States Volt Full time
Job Title: Regulatory Affairs Specialist II

Volt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory matters.

Key Responsibilities:
  • Support daily Regulatory Affairs function, including compliance with 21 CFR 820, 807, and 803 ISO 13485 requirements, company policies, operating procedures, processes, and promotional task assignments.
  • Provide regulatory support in Manufacturing Plant Transition Project and Quarterly Management Reviews.
  • Initiate, review, and approve NCMRs, CAPAs, reworks, and other regulatory documents.
  • Review and provide regulatory feedback on risk management plans/reports, Health Hazard Analysis, and Adverse events.
  • Communicate with agencies for notifications, field actions, adverse events, and significant/non-significant changes.
  • Maintain Design Dossiers and Letter to Files.
Requirements:
  • Bachelor's degree (BS, BA) in a relevant field.
  • Currently have or pursuing a Master's in Regulatory Affairs.
  • 4 years' regulatory experience.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Multitasker and quick learner.
  • Strong verbal and written communication skills.
What We Offer:

Volt offers a competitive pay rate, ranging from $38 to $39.36 per hour, based on experience and qualifications. We also offer a comprehensive benefits package, including health, dental, vision, term life, short-term disability, AD&D, 401(k), sick time, and other types of paid leaves.

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to providing 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 we operate.

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