Easter Seals Jobs

Job Title: Regulatory Affairs Specialist

Job Description

We are seeking an experienced Regulatory Affairs Specialist to head their own projects and submit 510(K)s to the FDA. The ideal candidate will have a strong background in 510(K) submissions, the ability to interpret and apply regulatory requirements, and excellent technical writing skills. Responsibilities include researching regulatory issues, providing guidance to cross-functional teams, reviewing labeling and advertising for compliance, and identifying regulatory pathways for product designs. The role also involves executing domestic and international regulatory submissions, tracking application statuses, assessing product changes for regulatory impact, and building strategic partnerships. Additionally, the specialist will monitor the regulatory environment and maintain positive communications and collaborations.

Hard Skills

• Medical Device Regulatory Affairs

• Quality Assurance

• GMP Medical Device

• FDA

• 510K

Soft Skills

• Efficient Project Management

• Technical Writing

• Cross-functional Team Guidance

• Strategic Partnerships

• Effective Communication

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.