Job Title: Associate Regulatory Affairs Specialist, Operations

Job Description

The Associate Regulatory Affairs Operations Specialist will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data. This role involves providing submission publishing/verification support and ensuring regulatory compliance.

Responsibilities

• Archive correspondence sent to and received from Regulatory Agencies and Notified Bodies
• Support the publishing of worldwide regulatory submissions in compliance with geography-specific regulatory requirements
• Support verification and quality review of submissions and other responses to regulatory agencies
• Track and support original and renewals of annual licenses and registrations/listings, and collect/organize/disseminate registration renewal documentation as required
• Track and process systems for required payments of registrations, listings, submissions, and other regulatory-regulated expenses
• Provide country-specific regulatory support
• Notarize business documents
• Procure document authentications, legalizations, and certifications
• Contribute to process improvement projects
• Ensure personal compliance with applicable company policies and procedures
• Perform other duties as needed

Essential Skills

• Bachelor's degree or equivalent experience. A degree in science, math, engineering, or medical fields is preferred
• 0-2 years of experience in the medical device, life science, or pharmaceutical industry, with a preference for experience in regulatory affairs
• Proficiency with MS Word, SharePoint (or equivalent), Excel, Adobe, and PowerPoint
• Ability to work collaboratively in a fast-paced environment and perform multiple tasks concurrently with accuracy
• Flexibility with changing priorities, ability to manage multiple tasks, prioritize, and schedule work to meet business needs and timelines
• Organized, detail-oriented, with strong planning and time management skills
• Ability to complete short- and long-term projects of moderate complexity with some guidance
• Sound and ethical judgment within policy and regulations
• Analytical thinking and good problem-solving skills
• Clear and effective verbal and written communication skills with various levels of the organization

Additional Skills & Qualifications

• Notary Public is a plus

Work Environment

This role is onsite in Santa Clara, Monday through Friday, working closely with a team of four. The team maintains a very close-knit culture with good communication.

Pay and Benefits

The pay range for this position is $31.00 - $33.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Santa Clara,CA.

Application Deadline

This position is anticipated to close on Mar 13, 2025.

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.

Salary : $31 - $33