Job Information
Actalent Regulatory Affairs Associate in Dallas, Texas
Description:
The overall goal of the Regulatory Affairs Associate is to ensure regulatory clearance for all company products in all markets and compliance with all applicable regulations. The Regulatory Affairs Associate will have a full understanding of the company product portfolio.
Principal duties and Responsibilities:
• Draft and submit regulatory registrations in US and EU and ensure project deadlines are met
• Work with R&D to create and maintain DHF documents and Technical Documentation
• Provide regulatory strategies for product development projects.
• Submit notifications of significant changes to competent authorities, notified bodies, and authorized reps
• Answer questions from competent authorities, notified bodies, authorized reps, and international distributors and provide documentation as needed
• Ensure compliance with regulatory and registration requirements in all jurisdictions
• Keep up to date with changes in regulatory legislation and guidance
• Conduct annual audits and review contracts of authorized reps and international distributors
• Provide regulatory support during third party audits of the company quality system and product documentation
• Work with QA to update Post-Market Surveillance plans and reports annually and to submit PSURs and SSCPs as required
• Maintain familiarity with company product lines
• Advise company regarding policies, practices, and systems to assure compliance with regulations and requirements of competent authorities.
Skills:
regulatory affairs, medical device, regulatory submission, fda, quality assurance
Additional Skills & Qualifications:
• Bachelor’s degree required.
• 3+ years’ experience in progressive positions with responsibilities for regulatory affairs in the international medical device market.
• Demonstrated success in medical device regulatory submissions in the US and EU under MDR
• Highly oriented to customer service and quality improvement.
• Ability to work in a fast paced, “driven” organization.
• Strong written and verbal communication skills.
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.