Senior Regulatory Affairs Specialist

Santa Clara, CA, US • Posted 4 days ago • Updated 4 days ago
Contract W2
12 Months
On-site
$50 - $52/hr
Fitment

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Job Details

Skills

  • submmsion
  • regulatory
  • labeling

Summary

Build your future with Volt!
Volt is immediately hiring Senior Regulatory Affairs Specialist in Santa Clara, CA
As a Regulatory Affairs Specialist, you will:

  • Review product labeling, promotional materials, and marketing content for regulatory accuracy and compliance.
  • Support integration activities by developing regulatory plans and strategies for acquired products and businesses.
  • Prepare, compile, and submit regulatory documentation packages for new and existing products.
  • Research and interpret national, regional, and global regulatory requirements.
  • Collaborate with cross-functional teams to gather information and address regulatory challenges.
  • Maintain current knowledge of evolving regulatory requirements and assess their impact on company products.
  • Identify, evaluate, and mitigate regulatory risks while ensuring compliance.
  • Support license renewals, annual registrations, and regulatory maintenance activities.
  • Respond to inquiries from regulatory authorities and customers regarding product compliance.
  • Represent the company in interactions with external regulatory bodies, standards organizations, and industry groups.
  • Participate in integration and project team meetings while independently managing assigned regulatory activities.

This is a full-time- contract opportunity.

The Ideal Candidate will have:

  • Bachelor's or master s degree in Life Sciences, Regulatory Affairs, Pharmacy, Chemistry, Biology, or a related field.
  • Minimum 4+ years of regulatory affairs experience in a highly regulated industry such as pharmaceuticals, diagnostics, medical devices, biotechnology, or life sciences.
  • Strong knowledge of U.S. and international regulatory requirements.
  • Experience preparing regulatory submissions and supporting product registrations.
  • Ability to interpret regulations and develop practical regulatory strategies.
  • Excellent written and verbal communication skills.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Demonstrated ability to work independently and proactively solve problems.

Preferred Qualifications

  • Experience supporting mergers, acquisitions, or product integration projects.
  • Regulatory Affairs Certification (RAC) or other relevant certifications.
  • Experience with diagnostic, laboratory, or life science products.
  • Proven ability to influence cross-functional teams and drive compliance initiatives.

PAY RANGE AND BENEFITS:

Pay Range*: $50 - $52 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 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 or call . 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.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from VOLT and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10115307
  • Position Id: 9000300
  • Posted 4 days ago
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