What Does a Regulatory Specialist Do?
Regulatory specialists ensure that their company is compliant with all applicable regulations and standards in a wide range of industries, including pharmaceuticals, medical devices, and consumer products. These experts interpret and research regulations and standards, develop compliance policies and procedures, and provide training and guidance to employees on regulatory matters. Additionally, they advocate for their company’s interests and provide feedback on proposed regulations to government agencies and industry associations.
A successful regulatory specialist needs excellent research and analytical skills, a keen eye for detail, and the ability to communicate complex regulatory issues to a variety of audiences. Professionals in this role should also have a deep understanding of the relevant regulations and standards in their industry, as well as the ability to stay updated with any changes.
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National Average Salary
Regulatory specialist salaries vary by experience, industry, organization size, and geography. To explore salary ranges by local market, please visit our sister site zengig.com.
The average U.S. salary for a Regulatory Specialist is:
Regulatory Specialist Job Descriptions
The Regulatory Compliance Specialist, as part of the Quality team, will interact with every level and group in the organization including external customers. The Specialist must be able to work independently without a set day-to-day schedule to ensure regulatory and quality requirements are met and drive product quality via manufacturing process improvements and customer satisfaction.
- Involved in the recall/correction process, drafting of notices, and own action plan if a recall is necessary
- Draft customer notifications and work with appropriate parties to distribute
- Coordinate/co-facilitate customer audits and associated activities
- Assist in regulatory audits in any needed capacity
- Own regulatory compliance submissions and coordination for approval
- Serve as Quality contact for any supplier issues or changes
- Perform customer audits as needed
- Serve as subject matter expert to assist with marketing content, technical support, and review of materials (customer-facing quality document owner)
- Compile, review, and submit any applications for use (510k through FDA, FCC, CE, etc.)
- Ensures that integration or product onboarding project goals are met
- Participate in the internal audit program
- Model personal Lean Philosophy 5S behaviors in creating a continuously improving, clean, well-organized, and self-maintaining work environment
- Follow a continuous improvement approach for achieving high-performance SQDC (Safety, Quality, Delivery, and Cost) targets through a visual work environment
- Comply with company ethics, code of conduct, policies, and best practices, with a commitment to safety in the workplace, valuing of diversity, and promotion of a harassment-free environment
- Perform other duties as assigned by management
- Bachelor of Science Degree
Experience and required skills
- Minimum 4 years of experience in a regulated manufacturing environment
- Previous experience with ISO 13485:2016
- Experience with 510(k) submissions preferred
- History of FDA/regulated audit involvement
- Excellent communication skills, written and verbal
- Quality Assurance Process, Audit and Control, and testing
- Experience and training in lean development and lean problem solving are desirable
- Change management
The Regulatory Specialist is responsible for promoting compliance with the regulatory requirements within ABC Company’s departments.
- Meets with the Regulatory department to organize deliverables and reviews materials
- Interacts with and represents the Clinical Vendor Management and Oversight department to auditors and responds to auditor requests
- Identifies organizational risks and helps implement process improvements
- Manages, coordinates, and participates in the implementation of contract changes for all lines of business pertaining to delegated vendors. Ensures that all processes and delegated vendors are in compliance with State and Federal regulations
- Reviews the delegated vendors’ policies, procedures, and correspondence to ensure compliance with CMS and DOH regulations
- Monitors all Corrective Action Plans (CAPs) through the completion
- Reviews timeliness of all monitoring reports to assess for compliance with regulatory time frames and develops CAPs for same if out of compliance
- Assists in accreditation submissions, regulatory surveys, and internal audits
- Additional duties as assigned
- High School Diploma or GED
- Bachelor’s degree from an accredited institution
- Previous relevant compliance experience
- Proficiency with Microsoft systems like Outlook, Excel, and Word
Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices.
- Using a broad base of knowledge and understanding of regulatory requirements assumes major responsibility for one or more major regulatory affairs areas
- Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
- Maintenance of sometimes complex existing licenses/certificates, product approvals, and simple post-market notifications
- Responsible for overall compliance with Regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve compliance
- Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues
- Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems, and recommends modifications to operate policies where appropriate
- The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department
- Bachelor’s degree in physical/biological sciences or engineering preferred, or the equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered
- Minimum 4 years experience in Regulatory Affairs
- In-depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
- Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
- Familiarity with regulatory standards and demonstrating general knowledge of individual products/geographies
- Demonstrated ability to author sections of a regulatory submission under supervision, with the content review at the end
- Qualified within the Regulatory function with a limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
- Recognize and awareness of gaps and potentially suggest solutions.
- Able to identify the adequacy of sections and overall content of submissions
- Knowledge and use of relevant PC software applications and skills to use them effectively
- Demonstrated ability to communicate effectively both verbally and in writing
- Must be highly skilled in timely and accurate decisions
- Demonstrated analytical and creative thinking skills and the ability to solve complex problems
Certificates, licenses, registrations
- Quality Assurance or Regulatory Affairs Certification (RAC) desired
How to Hire a Regulatory Specialist
Consider the following when hiring a regulatory specialist:
- Recruiting: Do you have the internal resources and tools to source and recruit for this role successfully?
- Complexity: Do you need a senior professional, or will mid, or even junior-level skills suffice?
- Duration: Is this a one-time project, or an indefinite need?
- Management: Can you effectively direct the work effort?
- Urgency: Are there any deadlines associated with this need?
- Headcount: Do you have the budget and approval for an internal employee, or should you consider alternate options?
Answering these questions will help determine the best course of action for your current hiring need. Fortunately, various great options exist for every scenario, no matter how unique. We recommend the following options when hiring a regulatory specialist:
1. Use 4 Corner Resources (or another professional recruiting firm)
The heavy lifting is done for you when working with a top-tier staffing company like 4 Corner Resources. We source, screen, recruit, and deliver only the most qualified candidate(s), saving you significant time and effort throughout the hiring process while you remain focused on your core business. Understanding your needs and ensuring the right candidate for the position is the key to our success.
This is the best route to take when:
- You need to fill the position quickly
- You want access to a vast talent pool of high-quality, prescreened candidates
- Your position is suited for temporary hiring services, contract staffing, or contract-to-hire recruiting, and you intend to direct the work activity.
- You are hiring an employee as a direct placement but aren’t able to recruit effectively or efficiently with your internal staff.
- You aren’t familiar with current salary rates, market trends, and available skill sets
2. Advertise your opening on a top job board
Your best option may be to advertise your opening on a proven job board. There are many widely used job sites out there that draw visits from qualified candidates. If you have someone internally who can dedicate the time and energy to sort through applications and screen individuals effectively, this can be a great choice.
We recommend using a job board when:
- Your internal recruiting team has the knowledge and experience to assess candidate qualifications
- You are hiring a direct employee and have time to manage the entire recruiting effort
- You have a process for receiving, screening, and tracking all resumes and applications
- You are prepared to respond to all applicants
There are many career sites out there. Here are the two we recommend for a regulatory specialist opening:
LinkedIn is a social network for job seekers, professionals, and businesses. With this popular job site, you can enhance your brand and advertise your open position to a wide audience of motivated, qualified candidates. Job postings on LinkedIn are also extremely streamlined and user-friendly, making it even easier for candidates to apply. Additionally, applicants can use their LinkedIn profile instead of a resume to expedite the process.
CareerBuilder has been a trusted source for hiring since 1995. Reach 80+ million unique, diverse U.S. job seekers annually by posting your jobs through their talent acquisition channels. Through CareerBuilder, you can engage candidates and drive them into your sourcing pipeline. We recommend using CareerBuilder for hiring when you have the internal resources and processes to review, screen, and reply to all applicants.
3. Leverage your internal resources
You can utilize your own website, social media, and employees to assist in your search for top candidates.
A company website posting should be the first step in notifying prospective candidates that you are hiring. Social media can also be a powerful tool for spreading the word about your new opening. As far as exposure is concerned, this option can be as good as some job boards when you have a large enough following across various platforms, like LinkedIn, Instagram, Facebook, TikTok, and Twitter.
Current employees are every organization’s greatest asset. Encourage your internal team to promote job openings to their network by offering cash and other incentives.
We recommend these options when:
- Your brand has great name recognition
- You can consistently monitor and respond to candidate activity through your website and social media accounts
- You have a process in place to quickly and broadly communicate job openings and requirements
- You have an effective employee referral program in place
If you aren’t sure which path is best, schedule a discovery call today with our seasoned recruiting professionals. The 4 Corner team is on standby to help you find the best option for your unique hiring need.
Sample Interview Questions
- What experience do you have researching and interpreting regulations and standards, and how do you ensure compliance with them?
- How do you ensure that regulatory records and documentation are accurate, complete, and current?
- What steps do you take to incorporate the latest updates to regulations and standards into your compliance strategy?
- If you had to create compliance policies and procedures, how would you make sure they were easy to follow for employees and effective?
- Do you have experience training employees on regulatory issues, and how do you ensure that they are aware of the need to comply?
- What steps do you take to stay informed about proposed regulations and changes to existing regulations, and how do you work with government agencies and industry associations to advocate for your company’s interests?
- Have you been involved in a successful regulatory compliance project, and if so, what steps did you take to ensure it was completed on time and on budget?
- What steps do you take to ensure that your company’s products and services adhere to regulations and standards in different countries and regions?
- How do you work with employees and management to resolve non-compliance issues identified by audits and assessments?
- What steps would you take to resolve a complex regulatory issue with stakeholders?