Regulatory Affairs Specialist II

Build your future with Volt!

Volt is immediately hiring for a Regulatory Affairs Specialist II at Plymouth, MN.

As a Regulatory Affairs Specialist II, you will:

• Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training.
• Responsible for PSUR, CER, HHE, Impact assessments (Post market surveillance activities).
• Provide Regulatory support in Manufacturing Plant Transition Project.
• Provide Regulatory Support in Quarterly Management Reviews.
• Provides regulatory expertise in any significant or non-significant changes.
• Support in maintaining and developing global regulatory strategies.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assist in PMS activities.
• Review and provide regulatory feedback on risk management plans/reports, Health Hazard Analysis, Adverse events by working cross functionally with Quality and Design team.
• Intiate, Review and Approve, NCMRs, CAPAs, Reworks etc.
• Reviews product and manufacturing changes for compliance with applicable regulations.
• Reviews protocols and reports to support regulatory compliance and submissions.
• Assist in audit preps.
• Responsible for communicating with agencies for any Notification, Field actions, Adverse Events, Significant/Non-Significant Changes etc.
• Maintain Design Dossiers and Letter to Files.
• May provide assistance in processing pending invoices to any customers or agencies.
• Able to develop and maintain Risk Management.

This is a Full-Time Contract opportunity.

Schedule: Mon-Fri 8AM-5PM

The Ideal Candidate will have:

• Bachelor's degree (BS, BA).
• Currently have or perusing Masters in Regulatory Affairs.
• 4 years' Regulatory experience.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Multitasker and Quick Learner
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Payrate Range in Between - $38 - $39.36/hour

*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 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.

Job ID : 438402