Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist Job Description
We are seeking an experienced Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across multiple franchises and international markets. This role is responsible for assessing regulatory changes, coordinating impact assessments, driving implementation activities, and ensuring regulatory requirements are effectively integrated into quality systems, processes, and business operations. The ideal candidate will have experience in Regulatory Affairs, Regulatory Compliance, Regulatory Operations, Quality Systems, or Compliance within a regulated medical device environment and possess strong project management and stakeholder leadership skills.
Responsibilities
- Lead pan-franchise implementation of emerging global regulatory requirements across international markets.
- Assess new or changing international regulations to determine business impact, implementation needs, risks, and timelines.
- Coordinate cross-functional gap assessments and implementation plans to ensure regulatory requirements are incorporated into quality systems, procedures, labeling processes, and business operations to support continued market access and compliance.
- Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliate teams to drive timely and compliant execution.
- Monitor implementation activities, identify risks, and drive issue resolution to support on-time compliance.
- Support audit readiness activities across Regulatory Affairs functions by identifying compliance risks, quality system gaps, and remediation opportunities.
- Track audit observations, remediation activities, and compliance commitments through completion.
- Develop and maintain KPIs, dashboards, trackers, and governance reports to provide visibility into implementation progress, compliance risks, and key deliverables.
- Support regulatory audit readiness activities and participate in internal, external, and regulatory inspections as needed.
- Act as a key liaison between Regulatory Affairs, Quality, Regulatory Compliance, Labeling, and international affiliates to resolve complex regulatory challenges.
- Facilitate cross-functional governance meetings and drive decision-making and accountability.
- Influence stakeholders and align priorities across multiple functions and geographies.
- Communicate implementation plans, risks, and progress updates to stakeholders and leadership.
- Lead change management activities associated with regulatory and procedural updates.
- Manage change order activities required to support regulatory and quality system updates.
- Support management of post-approval regulatory commitments and associated deliverables.
- Identify and implement process improvements to enhance efficiency, visibility, and compliance within regulatory operations.
Essential Skills
- 5-7 years of experience in Medical device, pharmaceutical, biotechnology, or other highly regulated industry experience in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, Compliance, or a related function within a regulated medical device industry.
- Strong understanding of international regulatory requirements and global compliance frameworks.
- Experience supporting implementation of regulatory or compliance requirements across cross-functional organizations.
- Strong project management, organizational, and stakeholder management skills.
- Ability to work independently and drive initiatives with minimal oversight.
- Ability to drive a problem through resolution and implement mitigations.
- Ability to handle multiple streams simultaneously with timely execution.
Additional Skills & Qualifications
- Experience with medical device regulatory affairs and project management.
Work Environment
This is an on-site position in Santa Clara, with working hours from 8 AM to 5 PM.
Job Type & Location
This is a Contract position based out of Santa Clara, CA.
Pay and Benefits
The pay range for this position is $45.00 - $48.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)
Job Type & Location
This is a Contract position based out of Santa Clara, CA.
Application Deadline
This position is anticipated to close on Oct 16, 2026.
Workplace Type
This is a fully onsite position in Santa Clara,CA. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.