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Regulatory Affair Program Manager Jobs (NOW HIRING)

CYNET SYSTEMS

Regulatory Affairs Manager

Indianapolis, IN · On-site

$48 - $53/hr

Manage regulatory data and promote data stewardship within regulatory affairs teams. * Contribute ... Employee Assistance Program (EAP) * Career Growth and Professional Development Opportunities ...

Nipro Europe Group Companies

WI · On-site

We are looking for a Regulatory Affairs Manager who is experienced, hands‑on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium.

CYNET SYSTEMS

Regulatory Affairs Manager

Indianapolis, IN · On-site

$48 - $53/hr

Manage regulatory data and promote data stewardship within regulatory affairs teams. * Contribute ... Employee Assistance Program (EAP) * Career Growth and Professional Development Opportunities ...

MTF Biologics

Manager, Regulatory Affairs

Edison, NJ · On-site +1

$125K/yr

Overview Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.

Willdan Group, Inc.

Program Manager

Anaheim, CA · On-site

The Program Manager will work closely with stakeholders, program teams, and senior leadership to ... Build and maintain relationships with CPUC Energy Division staff, IOU regulatory affairs teams ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory ...

Willdan Group

Program Manager

California, MO · On-site

$110K - $150K/yr

Program Manager Remote Northern, CA, US 3 days ago Requisition ID: 3220 Salary Range: $110,000.00 ... Build and maintain relationships with CPUC Energy Division staff, IOU regulatory affairs teams ...

CorDx

Regulatory Affairs Manager - IVD

San Diego, CA · On-site

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory ...

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How much do regulatory affair program manager jobs pay per year?

As of Sep 11, 2026, the average yearly pay for regulatory affair program manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

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Regulatory Affairs Manager

Indianapolis, IN • On-site

CYNET SYSTEMS
IT Services • 501 - 1,000 employees
Learn more about CYNET SYSTEMSexternal

$48 - $53/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Posted 9 days ago

Job description

Job Overview:

Pay Range: $48.00hr - $53.00hr

Requirement/Must Have:

  • 3-5 years of experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs, Medical devices, Pharma, or Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
  • Knowledge of XX, US, China, and other international regulations.
  • Demonstrated ability to adequately interpret and implement quality standards.
  • Demonstrated ability to manage high complexity work and global projects.
  • Specialist knowledge in regulatory affairs.
  • Experience in solving complex, critical health authority issues.
  • Understanding of external environmental changes and precedents to navigate complex situations.
  • Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

Responsibilities:

  • Ensure products obtain regulatory approvals in defined markets in close cooperation with other functions.
  • Coordinate and compile documents and deliverables for submissions in a timely manner to support planned product registration timelines.
  • Maintain obtained regulatory approvals and licenses throughout the life cycle of the product by applying successful regulatory change controls.
  • Maintain efficiency and success of regulatory activities and strategies through clear agreements with other functions, stakeholders, and external partners.
  • Communicate and implement regulatory requirements and strategic aspects within the organization.
  • Oversee the development of submission and product registration dossiers for complex products and programs.
  • Develop and manage parts of comprehensive global regulatory submissions and registration plans.
  • Partner with stakeholders to understand and provide best solutions.
  • Develop external relationships that influence the current and future direction for products.
  • Contribute to audit preparation and participate in audit discussions.
  • Lead the organization to adapt to the evolving regulatory environment and requirements.
  • Create unique and innovative regulatory strategies to avoid regulatory obstacles and accelerate worldwide approvals.
  • Initiate activities independently and manage interactions across departments.
  • Troubleshoot issues as they arise and implement cost-effective solutions to ensure daily work is completed without jeopardizing compliance.
  • Identify problems before they occur and drive mitigation strategies.
  • Mentor junior regulatory employees and share knowledge across the organization.
  • Manage regulatory data and promote data stewardship within regulatory affairs teams.
  • Contribute to projects with an understanding of how business functions, systems, processes, and data management are connected.

Nice to Have:

  • Knowledge of international regulations and quality standards implementation is considered an advantage.

Skills:

  • Regulatory Affairs.
  • Submission Compilation.
  • Stakeholder Management.
  • Strategic Planning.
  • Change Control.
  • Audit Preparation.
  • Decision Making.
  • Problem Solving.
  • Agile Mindset.
  • Data Stewardship.
  • Strong verbal and written communication skills.
  • Excellent communication and presentation skills.
  • Ability to communicate effectively with stakeholders.

Qualification And Education:

  • Bachelor’s, Master’s, or PhD degree in a relevant field (IVDs, Medical Devices, Pharma, Biopharmaceutical).

Benefits:

Our Benefits Include:

  • Medical, Dental, and Vision Insurance
  • 401(k) Retirement Plan
  • Health Savings Account (HSA)
  • Disability Insurance (Short-Term and Long-Term)
  • Life and AD&D Insurance
  • Paid Sick Leave (where required by applicable state or local law)
  • Supplemental Insurance Plans
  • Identity Theft Protection
  • Pet Insurance
  • Employee Wellness Programs
  • Employee Assistance Program (EAP)
  • Career Growth and Professional Development Opportunities

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.


About Cynet Systems


Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

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About Cynet Systems

Sourced by ZipRecruiter

Cynet Systems Inc is a staffing and recruiting corporation nestled in Ashburn, VA, USA. Established in 2010, the company operates within the Information Technology and Services sector, specializing in providing effective workforce solutions to different business needs, including IT consulting, direct hire, and contract staffing services. Through the years, Cynet Systems has built an impressive portfolio, going beyond borders and expanding its operations internationally in Canada and India. Rooted in its core values of teamwork, leadership, and commitment, Cynet Systems helps businesses unlock their full potential by providing versatile and competent professionals that perfectly align with their needs. Fueled by their unwavering mission to deliver top-tier talent to businesses worldwide, Cynet Systems garnered various recognitions including SIA's fastest-growing staffing firms and Best Place to Work in Virginia for 2019.

Industry

It services

Company size

501 - 1,000 Employees

Headquarters location

Sterling, VA, US

Year founded

2010

Social media

Twitter

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