How to hire a regulatory affairs specialist

How to hire a regulatory affairs specialist, step by step

Here's a step-by-step regulatory affairs specialist hiring guide:

• Step 1: Identify your hiring needs
• Step 2: Create an ideal candidate profile
• Step 3: Make a budget
• Step 4: Write a regulatory affairs specialist job description
• Step 5: Post your job
• Step 6: Interview candidates
• Step 7: Send a job offer and onboard your new regulatory affairs specialist
• Step 8: Go through the hiring process checklist

What does a regulatory affairs specialist do?

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1. Identify your hiring needs

   The regulatory affairs specialist hiring process starts by determining what type of worker you actually need. Certain roles might require a full-time employee, whereas part-time workers or contractors can do others.

   Determine employee vs contractor status

   Is the person you're thinking of hiring a US citizen or green card holder?

   Yes

   No

   A regulatory affairs specialist's background is also an important factor in determining whether they'll be a good fit for the position. For example, regulatory affairs specialists from different industries or fields will have radically different experiences and will bring different viewpoints to the role. You also need to consider the candidate's previous level of experience to make sure they'll be comfortable with the job's level of seniority.

   This list shows salaries for various types of regulatory affairs specialists.

   Type of Regulatory Affairs Specialist	Description	Hourly rate
   Regulatory Affairs Specialist		$23-47
   Compliance Coordinator	A compliance coordinator specializes in ensuring that every aspect of a company adheres to its policies and regulations, including the state laws. Their responsibilities revolve around maintaining an active communication line with different departments to gather and analyze data, identifying vulnerable areas and risks, conducting internal investigations and inspections on compliance violations, assessing workforce performance, and reviewing product and systems documentation... Show more	$16-34
   Compliance Auditor	A compliance auditor is responsible for reviewing the company's policies and procedures, ensuring the organization's adherence to state and federal regulations. Compliance auditors inspect the operations of each department, adjusting internal guidelines as needed... Show more	$21-44

   Show more

2. Create an ideal candidate profile

   Common skills:

   • Regulatory Affairs
   • FDA
   • Regulatory Agencies
   • Medical Devices
   • Regulatory Compliance
   • Regulatory Submissions
   • Patients
   • Excellent Interpersonal
   • Regulatory Authorities
   • Regulatory Issues
   • EU
   • Regulatory Strategies
   • PMA
   • Product Development

   Check all skills

   Responsibilities:

   • Gather, evaluating, organizing, managing and collating information in a variety of formats.
   • Manage CRO (regulatory) in support of the company's approve product in Europe.
   • Manage and submit electronic EPA product registrations.
   • Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
   • Support complaint handling process and screening, ensure FDA 21 CFR compliance.
   • Close complaints receive from external customers in compliance with FDA, ISO, QSR and other regulatory guidelines.

   More regulatory affairs specialist duties

3. Make a budget

   Including a salary range in your regulatory affairs specialist job description helps attract top candidates to the position. A regulatory affairs specialist salary can be affected by several factors, such as geography, experience, seniority, certifications, and the prestige of the hiring company.

   For example, the average salary for a regulatory affairs specialist in South Dakota may be lower than in California, and an entry-level regulatory affairs specialist usually earns less than a senior-level regulatory affairs specialist. Additionally, a regulatory affairs specialist with certifications may command a higher salary, and working for a well-known company or start-up may also impact an employee's pay.

   Average regulatory affairs specialist salary

   $70,060yearly

   $33.68 hourly rate

   ---

   Entry-level regulatory affairs specialist salary

   $49,000 yearly salary

   Updated December 16, 2025

   Average regulatory affairs specialist salary by state

   Rank	State	Avg. salary	Hourly rate
   1	California	$91,593	$44
   2	District of Columbia	$82,469	$40
   3	Massachusetts	$80,110	$39
   4	New Jersey	$78,429	$38
   5	Minnesota	$73,290	$35
   6	Washington	$73,285	$35
   7	New York	$70,964	$34
   8	Ohio	$70,395	$34
   9	Illinois	$70,359	$34
   10	Pennsylvania	$68,928	$33
   11	Texas	$67,530	$32
   12	Maryland	$66,761	$32
   13	Colorado	$64,075	$31
   14	Indiana	$62,296	$30
   15	Wisconsin	$61,263	$29
   16	Tennessee	$59,058	$28
   17	Florida	$58,183	$28
   18	Utah	$51,388	$25

   Average regulatory affairs specialist salary by company

   Company

   Rank	Company	Average salary	Hourly rate	Job openings
   1	Meta	$116,972	$56.24	9
   2	Pacific Gas and Electric	$102,846	$49.45
   3	Bloomberg	$102,036	$49.06	3
   4	Novartis	$101,693	$48.89
   5	AbbVie	$101,629	$48.86	9
   6	Windels Marx Lane & Mittendorf	$101,421	$48.76
   7	Intuitive Surgical	$100,737	$48.43	3
   8	Edwards Lifesciences	$100,135	$48.14	3
   9	Lyft	$99,868	$48.01
   10	Genentech	$99,395	$47.79	1
   11	BP America Inc	$99,218	$47.70
   12	Biogen	$99,189	$47.69
   13	Boehringer Ingelheim	$97,401	$46.83	5
   14	eBay	$96,985	$46.63
   15	Zenefits	$96,789	$46.53
   16	Bayer	$96,299	$46.30
   17	Federal Reserve Bank of New York	$95,589	$45.96
   18	Natera	$95,414	$45.87
   19	Varian Medical Systems	$94,928	$45.64
   20	JUUL	$94,701	$45.53	1

4. Writing a regulatory affairs specialist job description

   A regulatory affairs specialist job description should include a summary of the role, required skills, and a list of responsibilities. It's also good to include a salary range and the first name of the hiring manager. Below, you can find an example of a regulatory affairs specialist job description:

   Regulatory affairs specialist job description example

   At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do.
   
   Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
   Owens & Minor teammate benefits include:
   Medical, dental, and vision insurance, available on first working day 401(k), eligibility after 30 days of employment Employee stock purchase plan Tuition reimbursement Development opportunities to grow your career with a global company
   
   Job Summary
   
   This will be a remote position. The Regulatory Affairs Specialist II provides leadership in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants and the like to obtain and maintain regulatory filings, registrations and compliance. The Regulatory Affairs Specialist II reports to the Associate Director of Regulatory Affairs. The individual is responsible for monitoring design, documentation, and change control processes to assure policies, procedures and practices are in compliance with appropriate regulatory requirements. This individual provides analytical, interpretive and evaliuatiive solutions to complex problems through specialised regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinate activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority. position is responsible for directing and coordinating activities necessary to ensure global regulatory compliance with FDA, Canadian, European and other agency regulations. This position will manage division regulatory activities and serve as the direct liaison with regulatory agencies, as well as with other internal functional departments for new product development strategy. This position also oversees existing division products and obtains marketing approval for new/modified device applications.
   
   Core Responsibilities
   Assists the research and development team during new products development as well as assists in design control processes Provides global regulatory assessment and pathway(s) Obtains regulatory verification and confirms global strategy for new product development Determine regulatory filing strategies and submission types Develops, submits and coordinates with internal partners for filings of 510(k), IDE, PMA, ANDA, NDA, Technical Files and Design Dossiers for regulatory approval and clearance world wide Reviews and makes final determinations for regulatory assessments of proposed changes to existing products Reads, reviews, interprets and keeps current with regulations and publications regarding device and PPE products with primary focus on medical devices Manages necessary corrective action in all areas of responsibility which leads to improved product quality, process efficiency, minimum corporate exposure, and maximum profitability Ensures that all necessary quality assurance, regulatory and validation procedures and policies are in place and up to date Manages company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports Directs and reviews company self-audit and corrective action programs to ensure compliance with Good Manufacturing Practices (GMPs) and Medical Device amendments Maintains appropriate relationships with foreign and domestic regulatory governmental agencies by serving as a liaison Active participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibility Provides technical assistance and consultation to marketing, manufacturing, and customers regarding raw material selection, competitor product evaluation, and troubleshooting Reviews and approves promotional materials for use in markets of responsibility Provides assistance to contracts and sales with regards to product registration status and product characteristics needs for contracts
   
   Qualifying Experience
   Bachelor's degree in biological sciences, microbiology chemistry or engineering required; Graduate studies in Regulatory Affairs preferred RAC certified professional and project management skills desirable 5+ years experience in Regulatory Affairs in a medical device company Experience in dealing with FDA, Notified Bodies and other regulatory agencies Working knowledge of ISO and applicable International regulations, compliance and audit practices Intermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word) Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision 25% domestic travel
   
   We also invite you to connect with the Recruiter via LinkedIn. #LI-TP1
   
   If you feel this opportunity could be the next step in your career, we encourage you to apply.
   
   Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

   Copy this example

   

5. Post your job

   To find regulatory affairs specialists for your business, try out a few different recruiting strategies:

   • Consider internal talent. One of the most important talent pools for any company is its current employees.
   • Ask for referrals. Reach out to friends, family members, and your current work to ask if they know any regulatory affairs specialists they would recommend.
   • Recruit at local colleges. Attend job fairs at local colleges to recruit entry-level regulatory affairs specialists with the right educational background.
   • Social media platforms. LinkedIn, Facebook, and Twitter have more than 3.5 billion users, and they're a great place for company branding and reaching potential job candidates.

   Post your job online:

   • Post your regulatory affairs specialist job on Zippia to find and recruit regulatory affairs specialist candidates who meet your exact specifications.
   • Use field-specific websites.
   • Post a job on free websites.

6. Interview candidates

   During your first interview to recruit regulatory affairs specialists, engage with candidates to learn about their interest in the role and experience in the field. During the following interview, you'll be able to go into more detail about the company, the position, and the responsibilities.

   It's also good to ask about candidates' unique skills and talents to see if they match your ideal candidate profile. If you think a candidate is good enough for the next step, you can move on to the technical interview.

   The right interview questions can help you assess a candidate's hard skills, behavioral intelligence, and soft skills.

7. Send a job offer and onboard your new regulatory affairs specialist

   Once you've decided on a perfect regulatory affairs specialist candidate, it's time to write an offer letter. In addition to salary, it should include benefits and perks available to the employee. Qualified candidates may be considered for other positions, so make sure your offer is competitive. Candidates may wish to negotiate. Once you've settled on the details, formalize your agreement with a contract.

   It's equally important to follow up with applicants who don't get the job with an email letting them know that the position has been filled.

   Once that's done, you can draft an onboarding schedule for the new regulatory affairs specialist. Human Resources should complete Employee Action Forms and ensure that onboarding paperwork is completed, including I-9s, benefits enrollment, federal and state tax forms, etc. They should also ensure that new employee files are created for internal recordkeeping.

8. Go through the hiring process checklist

   • Determine employee type (full-time, part-time, contractor, etc.)
   • Submit a job requisition form to the HR department
   • Define job responsibilities and requirements
   • Establish budget and timeline
   • Determine hiring decision makers for the role
   • Write job description
   • Post job on job boards, company website, etc.
   • Promote the job internally
   • Process applications through applicant tracking system
   • Review resumes and cover letters
   • Shortlist candidates for screening
   • Hold phone/virtual interview screening with first round of candidates
   • Conduct in-person interviews with top candidates from first round
   • Score candidates based on weighted criteria (e.g., experience, education, background, cultural fit, skill set, etc.)
   • Conduct background checks on top candidates
   • Check references of top candidates
   • Consult with HR and hiring decision makers on job offer specifics
   • Extend offer to top candidate(s)
   • Receive formal job offer acceptance and signed employment contract
   • Inform other candidates that the position has been filled
   • Set and communicate onboarding schedule to new hire(s)
   • Complete new hire paperwork (i9, benefits enrollment, tax forms, etc.)

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