Regulatory Specialist Job Descriptions, Average Salary, Interview Questions

Here at [Your Company Name], we prioritize thoroughness, attention to detail, and above all else an unbending commitment to consumer safety and satisfaction. It is the job of a regulatory specialist to help corporations and organizations comply with all regulations pertaining to the products they manufacture, market, and/or distribute. This includes international regulations, federal regulations, and state regulations, in addition to the regulations governing specific industries. A competent regulatory specialist must possess a good memory and a keen eye for minutiae. Our regulatory specialists are expected to familiarize themselves with all relevant regulations so as to ensure that our products are held to the highest possible standard at all times.

Typical duties and responsibilities

• Interviewing executives, managers, and employees to determine compliance-related priorities.
• Providing advice on regulatory affairs requirements for all proposed changes to device design.
• Ensuring product design and R&D development teams adhere to regulatory controls.
• Building and maintaining strong partnerships with regulatory authorities.
• Addressing customer issues and concerns and ensuring repetitive occurrences do not occur. 
• Ensuring continuous compliance for all products.
• Compiling regulatory submissions to regulatory and consumer agencies.
• Overseeing inspection/audit activities and following up on any required actions assigned.
• Creating and implementing quality systems improvements.
• Ensuring compliance records are properly maintained.
• Maintaining and updating documentation, processes, and practices.
• Coordinating regulatory compliance procedures across organizational structures.
• Providing training in compliance practices and procedures.
• Keeping up to date on regulatory changes and developments in the regulatory environment.

Education and experience

• Bachelor’s degree in Biology, Chemistry, other science fields, or in the field of regulatory specialization.
• 5+ years experience in a relevant industry.
• 3+ years experience as a regulatory compliance specialist.

Required skills and qualifications

• Extensive knowledge of industry regulations and governing laws.
• Proficient in office and compliance management software.
• Strong analytical, investigative, and organizational skills.
• Excellent attention to detail.
• Solid interpersonal and communication skills.
• Excellent written and verbal communications skills.
• Ability to effectively negotiate with regulatory, technical, medical, and legal professionals.
• Strong computer skills and Microsoft Office skills.
• Ability to work under pressure.

Preferred qualifications

• Able to quickly adapt to changes in regulatory law as they develop
• Strong communication skills
• 2+ years of experience

Position summary

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.

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 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

Education

• 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

Minimum qualifications

• High School Diploma or GED

Preferred qualifications

• 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.

Responsibilities

• 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

Education

• 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

Experience

• Minimum 4 years experience in Regulatory Affairs

Skills

• 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