Description:

This company is a local orthodontics company who has been around for 40 plus years in Franklin, IN. They proudly design and manufacture their products in the USA, and are registered to sell them in 93 countries. Supporting many product lines used for orthodontic clients.

This position will report directly to the regulatory affairs director. This role involves preparing documentation to support international product registration, maintaining registration files and electronic databases. It requires preparing documents for notarization, legalization, and shipping, as well as tracking documents needed for product registrations within the company's regulatory framework. The position entails participating in inspections and audits conducted by notified bodies or other international regulatory agencies. It also involves reviewing new regulations and contributing to the development of relevant procedures. Supporting regulatory compliance through activities such as labeling, certificates of analysis, certificates of conformity, safety alert monitoring, and other tasks is expected. Maintaining regulatory listings with agencies like the FDA and Health Canada is part of the responsibilities.

Must Haves:

1. Bachelors Degree in Engineering (chemical, industrial, biomedical, mechanical)

2. 1-3 years experience working in regulatory for a medical device company

3. Experience working with the FDA and non US regulators

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.