Job Information
Actalent Regulatory Affairs Associate in Dallas, Texas
Job Title: Regulatory Affairs AssociateJob Description
The Regulatory Affairs Associate ensures regulatory clearance for all company products across all markets while maintaining compliance with all applicable regulations. This role involves drafting and submitting regulatory registrations in the US and EU, collaborating with R&D to maintain DHF documents and Technical Documentation, and providing strategic regulatory advice for product development projects. Additionally, the associate will handle notifications of significant changes, respond to inquiries, and support during audits, ensuring all regulatory, registration, and compliance requirements are met efficiently.
Hard Skills
Experience in regulatory submissions
Knowledge in drafting documents for EU MDR
Familiarity with document classifications and regulatory requirements in US (FDA) and EU (EU MDR)
Soft Skills
Ability to manage multiple projects and meet deadlines
Strong communication skills for interacting with authorities and international distributors
Detail-oriented with strong problem-solving skills
Job Type
This is a contract position with a duration of 9 Month(s).
Work Site
This is a fully on-site position in Dallas, Texas.
Work Environment
Reporting to the Regulatory Affairs Manager, the role involves collaborating closely with R&D, QA, and other departments to ensure compliance and support product development. The associate will also be involved in conducting annual audits and reviewing contracts, requiring a proactive approach to staying updated with regulatory changes and guidance.
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.