Regulatory Affairs Associate in Alameda, California

Job Title: Regulatory Affairs AssociateJob Description

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

• Authoring and submitting PMA supplements, 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.

• Review and approval of engineering study protocols/reports and validation study protocols/reports.

• Review and approval of manufacturing changes for Class III implantable medical devices.

• May require an advanced degree and 5-8 years of direct experience in the field.

• Recent experience with Class III implantable medical devices is essential.

• Proven successful track record of authoring, submission, and approval of Class III implantable PMA supplements.

• Knowledge of FDA PMA guidance documents and CFR regulations is critical.

• Relies on extensive experience and judgment to plan and accomplish goals.

• Performs a variety of tasks and may lead and direct the work of others.

• A wide degree of creativity and latitude is expected.

Job Type

This is a contract position with potential to extend.

Work Site

This is a fully on-site position in Alameda, California.

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 [email protected] (%[email protected]) for other accommodation options.