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Actalent
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Regulatory Affairs Specialist
Actalent Aliso Viejo, CA
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$110k-141k (estimate)
Other 1 Week Ago
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Actalent is Hiring a Regulatory Affairs Specialist Near Aliso Viejo, CA

Description:

Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submissions Have experience supporting internal and external inspections Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities This position will be working with multiple business units to develop update and improve regulatory affairs processes. Assist the strategy implementation and operations for regulatory affairs activities including directing development of product registration submission progress reports supplements amendments or periodic experience reports. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape including EU MDR. Identify opportunity for regulatory affair processes and drive changes to completion.

Skills:

regulatory affairs, medical device, EUMDR, regulatory submission, regulatory documents

Top Skills Details:

regulatory affairs,medical device,EUMDR

Additional Skills & Qualifications:

3-5 years of regulatory in medical device

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Job Summary

JOB TYPE

Other

SALARY

$110k-141k (estimate)

POST DATE

06/06/2024

EXPIRATION DATE

08/05/2024

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