Senior Regulatory Affairs Specialist

JOB DESCRIPTION

• Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.

• Assist in maintaining the Quality Management System to ensure domestic and international standards are met.

• Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.

• Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.

• Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.

• Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.

SKILLS& QUALIFICATIONS

REQUIRED

• 3-5 years of progressive experience in regulatory affairs required

• Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required

PREFERRED

• Bachelor's degree in a science, mathematics, engineering or other technology field

• Experience with EU MDR Technical Documentation

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.