Regulatory specialist

Volt Management Corp. Regulatory Specialist - Master 434967 Amory, Mississippi Apply Now

To be considered for an interview, please make sure your application is full in line with the job specs as found below.

Responsibilities :

• Develop and implement programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national / regional / global regulations.
• Prepare document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
• Compile materials required in submissions, license renewal and annual registrations and maintain updated information about national / regional / global regulatory requirements.
• Proactively manage the changing regulatory environment for company products, preventing barriers to trade, eliminating duplication of effort and identifying and mitigating areas of risk.
• Review product labeling and marketing materials for accuracy and compliance with regulations.
• Respond to customers' and / or authorities' requests / inquiries dealing with regulations and product compliance.
• Represent the company in external bodies dealing with standards and / or product regulations at the national / regional / global level.
• Assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

This is a full-time, contingent opportunity.

Qualifications :

• Bachelor's or master's degree in engineering / scientific discipline.
• 8 years of relevant regulatory / compliance experience.
• IVDR or MDR experience in Europe.
• Regulatory Affairs / Compliance certifications are a plus (RAPS, RAC, GRACP, etc.).
• Ability to work remotely, preferably on EST time.

Pay Rate : $45.00 - $52.10 per 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 back in touch as soon as possible.

Benefits : Volt offers benefits (based on eligibility) that include 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.

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.

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Last updated : 2024-10-03

Salary : $45 - $52