Description:In this role, they need someone to oversee regulatory compliance with a medical device company they just acquired. The individual will be responsible for validation testing, clinical study management. Also responsible for managing fitness UL requirements. Stay abreast of regulatory changes and updates from UL, FDA, CSA, NSF, FFA, and CE to ensure compliance with applicable standards. Interpret and apply regulatory requirements to product design, development, and manufacturing processes. Develop and maintain regulatory compliance strategies for Class 1, Class 2, and Class 2a medical devices.Skills:Compliance, FDA, iso 13485, Regulatory compliance, Compliance engineeringTop Skills Details:Compliance,FDA,iso 13485Additional Skills & Qualifications:Bachelor's degree in engineering Minimum 5 years of regulatory experience primarily in med device Minimum 1 year of FDA and ISO 13485 experience working in that environment Minimum 1 year of UL requirement experienceAbout 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 [email protected] (%[email protected]) for other accommodation options.