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Regulatory affairs manager vs specialist

The differences between regulatory affairs managers and specialists can be seen in a few details. Each job has different responsibilities and duties. While it typically takes 2-4 years to become a regulatory affairs manager, becoming a specialist takes usually requires 1-2 years. Additionally, a regulatory affairs manager has an average salary of $117,714, which is higher than the $58,013 average annual salary of a specialist.

The top three skills for a regulatory affairs manager include regulatory affairs, FDA and medical devices. The most important skills for a specialist are patients, customer service, and work ethic.

Regulatory affairs manager vs specialist overview

Regulatory Affairs ManagerSpecialist
Yearly salary$117,714$58,013
Hourly rate$56.59$27.89
Growth rate-10%
Number of jobs12,569358,433
Job satisfaction--
Most common degreeBachelor's Degree, 64%Bachelor's Degree, 49%
Average age4742
Years of experience42

What does a regulatory affairs manager do?

A regulatory affairs manager is in charge of ensuring that all aspects of a company adhere to the rules and regulations set by regulatory agencies. Their responsibilities revolve around devising regulation compliance strategies, creating training and orientation programs to inform the staff on the policies and standards, conducting internal inspections and information drives, and keeping abreast with the latest rules and regulations. Moreover, a regulatory affairs manager is in charge of processing and submitting necessary documents to government agencies, ensuring compliance and timeliness.

What does a specialist do?

Specialists are employees who are responsible for specific tasks or activities in the department they are assigned to. The actions or tasks they work on are related to their educational background or work experiences. They are usually highly skilled in specializations related to the work they are assigned to. Specialists are also highly trained on the competencies that are required of their specialty. As such, they are focused on the skills and competencies that are needed to enhance their experience in their specific field further.

Regulatory affairs manager vs specialist salary

Regulatory affairs managers and specialists have different pay scales, as shown below.

Regulatory Affairs ManagerSpecialist
Average salary$117,714$58,013
Salary rangeBetween $78,000 And $177,000Between $32,000 And $104,000
Highest paying CitySan Rafael, CAJersey City, NJ
Highest paying stateVermontNew Jersey
Best paying companyMcKinsey & Company IncThe Citadel
Best paying industry--

Differences between regulatory affairs manager and specialist education

There are a few differences between a regulatory affairs manager and a specialist in terms of educational background:

Regulatory Affairs ManagerSpecialist
Most common degreeBachelor's Degree, 64%Bachelor's Degree, 49%
Most common majorBusinessBusiness
Most common collegeUniversity of Southern CaliforniaStanford University

Regulatory affairs manager vs specialist demographics

Here are the differences between regulatory affairs managers' and specialists' demographics:

Regulatory Affairs ManagerSpecialist
Average age4742
Gender ratioMale, 45.8% Female, 54.2%Male, 47.5% Female, 52.5%
Race ratioBlack or African American, 7.7% Unknown, 4.7% Hispanic or Latino, 12.8% Asian, 9.0% White, 65.1% American Indian and Alaska Native, 0.7%Black or African American, 11.4% Unknown, 5.4% Hispanic or Latino, 16.4% Asian, 10.5% White, 55.9% American Indian and Alaska Native, 0.4%
LGBT Percentage10%11%

Differences between regulatory affairs manager and specialist duties and responsibilities

Regulatory affairs manager example responsibilities.

  • Implement and achieve ISO 9001 and ISO 13485 registrations for the first time for the company.
  • Manage team which monitor the clinics' daily, weekly and monthly water and equipment maintenance requirements to meet CMS regulations.
  • Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.
  • Coordinate, oversee and audit record-keeping requirements of DEA, OSHA, D.O.T.
  • Conduct a comprehensive risk assessment of health plan with results from CMS audit as benchmark.
  • Perform all AML functions on new and existing customers, including OFAC checks and CIP.
  • Show more

Specialist example responsibilities.

  • Create, manage, and assist users with SharePoint sites.
  • Manage an on-site IRB and company good clinical practice (GCP) inspection.
  • Manage SharePoint sites by creating, editing, and customizing company sites, libraries and security.
  • Manage the building of accounts, assigning of static IP's, and scheduling of business class installations.
  • Convert servers from UNIX to Linux, all hardware diagnostics and repair including printers/plotters/desktops etc.
  • Follow safety procedures such as maintenance of all equipment (Telxon scanners, terminals and ladders).
  • Show more

Regulatory affairs manager vs specialist skills

Common regulatory affairs manager skills
  • Regulatory Affairs, 11%
  • FDA, 8%
  • Medical Devices, 6%
  • Regulatory Submissions, 5%
  • Regulatory Agencies, 5%
  • Global Regulatory, 5%
Common specialist skills
  • Patients, 15%
  • Customer Service, 11%
  • Work Ethic, 5%
  • Patient Care, 4%
  • Exceptional Client, 4%
  • Troubleshoot, 4%

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