Regulatory Specialist

Our client, a leading organization in the medical device industry, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will be part of the Regulatory Affairs Operations team supporting international labeling and compliance initiatives. The ideal candidate will have strong regulatory knowledge, excellent project management skills, and the ability to collaborate effectively across diverse teams and geographies, which will align successfully in the organization.

Job Title: Regulatory Specialist

Location:Santa Clara, CA

What's the Job?

• Lead and execute international addendum labeling requests, including Instructions for Use (IFUs), import labeling, and supplemental labeling.
• Manage project plans, timelines, and stakeholder communications to ensure timely and compliant implementation of labeling changes.
• Assess regulatory and quality system requirements to develop compliant labeling strategies for complex product portfolios.
• Collaborate with cross-functional teams across Regulatory Affairs, Quality, Supply Chain, and Manufacturing to drive alignment and resolve issues.
• Monitor emerging regulations and translate regulatory requirements into operational processes to ensure ongoing compliance.

What's Needed?

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related field.
• Minimum of 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, or Compliance within a regulated industry.
• Significant experience with medical devices, pharmaceuticals, or biotechnology products.
• Proven ability to develop regulatory labeling strategies and lead complex post-approval initiatives.
• Strong project management skills, including managing timelines, risks, and stakeholder expectations.

What's in it for me?

• Opportunity to work on impactful projects within a global organization.
• Collaborate with diverse and talented teams across multiple functions.
• Develop your expertise in regulatory labeling and compliance strategies.
• Be part of a company committed to continuous improvement and innovation.
• Contribute to the success of a leading organization in the medical device industry.

Upon completion of waiting period, consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.