Regulatory SpecialistJob Description, Salary, Career Path, and Trends
Regulatory specialists ensure that organizations meet all state, local, federal, international, and industrial regulations that apply to their products. They generally work in the food and beverage, pharmaceutical, and medical devices industries, though other companies that require regulatory compliance, such as those that produce automotive or mechanical components, also employ regulatory specialists.
Regulatory specialists should have strong analytical, project management, and communication skills. They must have experience in a regulatory position, complying with local, state, and federal regulations, presenting to regulatory authorities, and work well under strict deadlines.
Sample job description #1
The Regulatory Compliance Specialist, as part of the Quality team will interact with every level and groups 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.
Key job responsibilities
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 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 desirable
Sample job description #2
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 process and by 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 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
Sample job description #3
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 operating 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 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 demonstrates general knowledge with individual products/geographies
Demonstrated ability to author sections of a regulatory submission under supervision, with content review at end
Qualified within the Regulatory function with 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 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 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
Average salary and compensation
The average salary for a regulatory specialist is $95,500 in the United States. Position salary will vary based on experience, education, company size, industry, and market.
Los Angeles, California
Minneapolis-St. Paul, Minnesota
New York City, New York
Sample interview questions
“The letter of the law is less important than the spirit of the law.” Do you consider this statement to be true or false?
Can you point to an example in recent years of an organization failing to adhere to externally enforced regulations, be they international, federal or otherwise? What were the consequences for that organization? What should it have done differently, in your view?
You have just learned that [Your Company Name] is due to be audited. What is the first thing that you do in order to prepare us for this impending audit?
You have just identified some way in which [Your Company Name] is guilty of regulatory noncompliance. How would you go about conveying this oversight to the relevant authorities within and without [Your Company Name]?
Are you a capable communicator in your personal and professional life? Can you name a time when you successfully explained a complex issue to a layperson who did not share your expertise?
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