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Home/Roles/Regulatory Affairs Specialist

Legal & Compliance · Life sciences

Regulatory affairs staffing, matched to your product and your filings

Since February 2, 2026, FDA has applied the new Quality Management System Regulation, which incorporates ISO 13485, so device regulatory hires now need to work fluently in both FDA and ISO terms. Careerscape's remote recruiters specialize by field and run regulatory affairs searches nationwide for permanent, contract and contract-to-hire roles.

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  • Drugs, biologics, devices and combination products
  • RAC status and eligibility checked with RAPS
  • Permanent, contract and contract-to-hire
510(k)CMCEU MDRLabeling

Talent hubs

Regulatory affairs talent pools, metro by metro

BLS counts regulatory affairs specialists as compliance officers, a broader group that also covers bank, healthcare and corporate compliance staff. The May 2025 figures below cover that whole group, so read them as a rough map of regulatory and compliance talent.

All 29 markets
MarketJobsMedian pay · vs. U.S.Concentration
New York City23,380$101,050+25%0.92
Los Angeles17,700$94,810+17%1.05
Washington, DC13,820$100,200+24%1.64
Dallas12,530$77,760−4%1.15
Boston10,920$103,940+29%1.51
Miami10,530$79,770−1%1.39
Atlanta9,170$72,810−10%1.18
Houston8,450$78,860−2%0.96
Philadelphia8,370$83,000+3%1.08
Chicago8,320$82,020+2%0.69
Phoenix7,980$74,240−8%1.25
San Francisco7,500$118,890+47%1.18
Seattle6,440$95,850+19%1.15
San Diego6,120$101,230+25%1.48
Detroit5,180$81,250+1%1.01
Baltimore5,030$80,520±0%1.38
Denver4,830$83,580+4%1.12
Minneapolis4,610$91,150+13%0.88
Tampa4,110$75,920−6%1.06
Austin3,670$70,720−12%1.06
Charlotte3,240$86,720+7%0.89
Nashville3,200$62,210−23%1.08
Portland3,090$86,600+7%0.95
Pittsburgh2,730$70,560−13%0.91
Raleigh-Durham2,200$79,570−1%1.10
Buffalo2,180$82,450+2%1.52
Albany1,710$81,190+1%1.42
Providence1,480$87,620+9%0.77
Hartford1,390$93,890+16%0.86

Washington, DC has the highest concentration (1.64), followed by Buffalo (1.52), Boston (1.51) and San Diego (1.48). Boston and San Diego also pay well above the U.S. median of $80,730, at $103,940 and $101,230. San Francisco pays the most, $118,890, 47% above the national figure. New York City and Los Angeles have the largest pools by count. Chicago, Providence and Hartford have the lowest concentrations, and Nashville has the lowest median, $62,210. Because the group mixes industries, a high count does not by itself mean a deep pool of drug or device specialists. Our legal and compliance staffing page covers hiring by city. Compliance Officers, by metro area, sorted by jobs. BLS Occupational Employment and Wage Statistics, May 2025; U.S. median $80,730. Concentration is the BLS location quotient: above 1.0 means the job is a bigger share of local employment than nationally.

Specialties

Split the role by product and by function

A specialist who has filed 510(k)s may never have written a CMC section. Choose from each group before you write the posting.

Product type

  • Small-molecule drugs
  • Biologics
  • Cell and gene therapy
  • Medical devices
  • In vitro diagnostics
  • Combination products
  • Software as a medical device

Function

  • Regulatory strategy
  • CMC regulatory
  • Submissions and publishing
  • Labeling
  • Advertising and promotion review
  • Post-market and vigilance

Market

  • FDA (U.S.)
  • EU MDR and IVDR
  • Health Canada
  • Global and emerging markets

Systems

  • Veeva Vault RIM
  • eCTD publishing tools
  • Regulatory information management

2026 changes

Rule changes your next regulatory hire should already know

For device makers, the biggest shift is already in force. FDA's Quality Management System Regulation took effect on February 2, 2026. It amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, which makes risk management an explicit requirement. On the same date FDA stopped using its Quality System Inspection Technique (QSIT) and moved device inspections to an updated compliance program, 7382.850. Candidates who prepared sites for QSIT inspections should be able to explain what has changed for them.

In Europe, Regulation (EU) 2023/607 extended the MDR transition. Class III and class IIb implantable devices have until 2027 and most other legacy devices until 2028, provided the manufacturer met conditions such as applying to a notified body by May 26, 2024. The European Commission then proposed a targeted revision of the MDR and IVDR on December 16, 2025, which would, among other changes, remove the five-year maximum certificate validity. The European Parliament and Council must agree it before it applies, so check its status before planning around it.

At the agency itself, HHS announced in March 2025 a restructuring that would cut about 3,500 FDA positions, and said drug, device and food reviewers and inspectors would not be affected. Ask experienced candidates what they have seen in their own agency interactions since then.

510(k)CMC
Regulatory Affairs Specialist · Legal & Compliance

Dates to plan around

  • QMSR in effectFeb 2, 2026QSIT retired the same day
  • EU MDR: class III and IIb implantable2027Under Regulation (EU) 2023/607
  • EU MDR: most other legacy devices2028Conditions apply
  • MDR and IVDR revision proposedDec 16, 2025Needs Parliament and Council approval

Template

Draft posting for a regulatory affairs specialist

Built for a device or drug company with an in-house regulatory team. Keep the bracketed option that matches your product.

The regulatory affairs specialist prepares and manages [Company]'s submissions to FDA and other health authorities, keeps registrations and labeling current, and advises project teams on what each product change means for its regulatory status. The role reports to [the Director of Regulatory Affairs].

Responsibilities

  • Prepare, compile and submit [510(k)s, De Novo requests and EU technical documentation / IND amendments, NDA or BLA sections and annual reports].
  • Respond to agency questions and deficiency letters by the deadlines set.
  • Assess design, manufacturing and labeling changes for regulatory impact and document each decision.
  • Review labeling, promotional materials and technical documents for compliance before release.
  • Track new regulations, guidance and standards, and brief project teams on what changes.
  • Support FDA and notified body inspections and internal audits.
  • Maintain registrations, listings and regulatory databases.

Requirements

  • Bachelor's degree in a life science, engineering, pharmacy or a related field.
  • [2-5] years in regulatory affairs or a related function such as quality, clinical research or CMC.
  • Hands-on experience with [FDA device submissions / drug submissions in eCTD format].
  • Working knowledge of [21 CFR Part 820 and ISO 13485 / 21 CFR Parts 312 and 314].
  • Clear technical writing, with redacted samples available.

Nice to have

  • RAC-Drugs or RAC-Devices from RAPS
  • EU MDR or IVDR technical documentation experience
  • Veeva Vault RIM or another regulatory information system
  • Experience preparing for and attending FDA meetings

Before the offer

Five checks for a regulatory affairs candidate

Regulatory mistakes tend to surface months later, in a deficiency letter or an inspection, so run these checks before you extend an offer.

  • Confirm the RAC, and which one

    RAPS now issues RAC-Drugs and RAC-Devices and no longer accepts new applicants for the older RAC-US, RAC-Europe, RAC-Canada and RAC-Global, though existing holders can still recertify. Each RAC needs 36 recertification credits every three years.

  • Ask what they personally wrote

    Submission credit is shared. Ask which sections the candidate drafted, which they only compiled, and what the agency asked about each.

  • Match the product class

    Class II device experience is not PMA experience, and small-molecule CMC differs from biologics CMC. Hire for the submissions on your roadmap, not the ones in the past.

  • Read a writing sample

    Ask for a redacted deficiency response or regulatory assessment. Clear writing under tight constraints is most of the job.

  • Test quality-system fluency for device roles

    Under the QMSR, regulatory and quality work overlap more. A device candidate should explain how ISO 13485 risk management feeds into their change assessments.

BLS pay

Pay benchmarks for regulatory affairs hires

These national figures are for compliance officers, the BLS group that includes regulatory affairs specialists. The group mixes regulatory staff with compliance roles in banking, healthcare and government, so use the full spread rather than the median alone.

$48,22010th
$61,28025th
$80,730Median
$109,01075th
$133,72090th

Middle half of all workers (25th to 75th percentile)

The national median is $80,730. A specialist who just meets RAPS's minimum for the RAC exam, a bachelor's degree plus three years, is a reasonable fit for the median. A senior specialist who leads submissions sits closer to the 75th percentile ($109,010) or the 90th ($133,720). See the regulatory affairs specialist salary guide for more detail. Annual pay, all U.S. employers, BLS Occupational Employment and Wage Statistics (May 2025), occupation: Compliance Officers. BLS does not publish this title separately; the figures are for compliance officers, the closest BLS occupation, which can include other job titles. Pay by level and city: Regulatory Affairs Specialist salary guide.

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What regulatory support do you need?

Tell us the product type, the markets you file in, the submissions coming up and whether the need is permanent or project-based.

  • A short list of screened candidates, not a stack of resumes
  • Direct hire, contract, contract-to-hire or executive search
  • Review candidates and give feedback in your Employer Portal

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FAQ

Answers for teams staffing regulatory affairs

What does a regulatory affairs specialist do?

They get products approved or cleared and keep them compliant. O*NET's task list includes preparing and reviewing submissions, answering agency requests for information, advising project teams on premarket, labeling and clinical study requirements, reviewing promotional materials, coordinating recalls and tracking new regulations and guidance. In a small company one person covers all of it; larger companies split the work by product and function.

Who is eligible for the RAC exam?

RAPS requires a bachelor's degree plus at least three years of regulatory or regulatory-related experience, a master's plus two years, or a doctorate plus one year. Related experience can include quality assurance, quality control, clinical research tied to product approval or health product project management. Each exam has 100 multiple-choice questions over two hours, and exams run in spring, summer and autumn windows.

Is a RAC required to work in regulatory affairs?

No law requires it, and many experienced specialists do not hold one. It is useful evidence of breadth, especially for candidates moving over from quality or clinical roles. Keep it on the nice-to-have list unless a partner or customer requires it, and judge candidates mainly on the submissions they have written and defended.

When does contract regulatory staffing make sense?

Contract help suits a defined surge: a submission with a fixed date, EU MDR technical file work before a transition deadline, a labeling overhaul or cover for a leave. Careerscape offers contract staffing and contract-to-hire for these, and direct hire for permanent roles. Keep regulatory strategy with a permanent owner who will still be there for the agency's follow-up questions.

Do you recruit regulatory staff outside drugs and devices?

Yes. The same skills apply to food, cosmetics, chemicals and other regulated products, and BLS counts regulatory specialists with compliance officers across industries. Tell us the agency and product so the shortlist matches. For compliance roles in finance or healthcare, see our compliance officer hiring guide.

Related roles

  • Compliance Officer
  • Compliance Analyst
  • Clinical Coordinator
  • Corporate Counsel
  • All 48 roles

Also useful

  • Regulatory Affairs Specialist salary guide
  • Legal & Compliance recruiting by city
  • Legal & Compliance staffing services
Sources for this page

Last reviewed October 22, 2026.

  • BLS Occupational Employment and Wage Statistics, May 2025, SOC 13-1041 Compliance Officers, national and metro estimates, via Careerscape data packet
  • O*NET OnLine, 13-1041.07 Regulatory Affairs Specialists (checked Oct 22, 2026)
  • U.S. FDA, Quality Management System Regulation (QMSR)
  • HPRA (Ireland), MDR transitional provisions
  • Mason Hayes & Curran, EU Commission proposes reform of the Medical Devices Regulation (Dec 17, 2025)
  • HHS, Fact sheet: HHS restructuring (Mar 27, 2025)
  • RAPS, RAC (Drugs) and RAC (Devices)
  • RAPS, RAC Recertification

Have a submission or MDR deadline coming up?

Send us the scope. A recruiter who focuses on regulatory and compliance roles will confirm product and function fit before presenting a pre-screened shortlist.

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