Job Title: Regulatory Affairs Specialist

Job Description

This position is Non-Exempt. Hours over 40 will be paid at Time and a Half. Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple multidimensional mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units, and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users. 1-6 years experience required.

Hard Skills

• Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.

• Conduct reviews of product and manufacturing changes of instrument hardware and software for compliance with applicable regulations.

• Act as a regulatory representative on core product development teams, communicate regulatory requirements and impact of regulations to the development team. Provide guidance and expertise.

• Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.

• Maintain pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current, up-to-date, and are entered into regulatory submission database and file systems. Ensure that information on such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.

• Interface directly with FDA and other regulatory agencies.

• Work with cross-functional team to support product release process.

• Review protocols and reports to support regulatory submissions.

• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Work Site

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

Work Environment

Onsite Santa Clara M-F

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.