Regulatory Affairs Specialist

Actalent; Santa Clara (CA); On-site; USD 62,000 - 66,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short/long-term disability

HSA

Transportation benefits

PTO / Vacation

Employee Assistance Program

Job summary

Actalent in Santa Clara, CA is seeking a Senior Regulatory Affairs Specialist to drive global regulatory requirements across franchises and international markets. The role focuses on assessing regulatory changes, coordinating impact assessments, and embedding requirements into quality systems and operations.

The candidate should have 5–7 years of experience in regulated environments and strong project management and stakeholder leadership skills.

Qualifications

• 5-7 years in medical device, pharma, biotech or similarly regulated industries in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, or related functions.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience implementing regulatory or compliance requirements across cross-functional teams.
• Excellent project management, organizational, and stakeholder management skills.
• Ability to work independently, drive initiatives, and resolve issues.
• Ability to manage multiple streams with timely execution.

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 plans to embed regulatory requirements into quality systems and business operations.
• Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliates to drive compliant execution.
• Monitor implementation activities, identify risks, and drive issue resolution for on-time compliance.
• Support audit readiness activities by identifying compliance risks and quality gaps.
• Track audit observations, remediation activities, and compliance commitments through completion.
• Develop KPIs, dashboards, trackers, and governance reports to show progress and risks.

Skills

Regulatory affairs

Regulatory operations

Quality systems

Project management

Stakeholder management

Regulatory compliance

Job description

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.

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 [e-mail] 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.