Regulatory Affairs Specialist

DenMat Holdings, LLC•Lompoc, CA

1d•$66,500 - $90,802•Onsite

About The Position

This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company’s ongoing compliance. Provide guidance to Operations and other areas of the company on compliance issues with relation to area of expertise.

Requirements

Bachelor's degree (B.A./B.S.) from four-year college or university in a scientific field
2 - 4 years related professional experience
Ability to read, analyze, and interpret complex scientific and regulatory publications/documents.
Ability to respond effectively to complex regulatory issues and write technical and regulatory reports, documents, business correspondence, and procedures.
Ability to respond to questions or complaints from managers, customers, other employees of the organization and regulatory and government agencies.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to use word processing, spreadsheet, and database applications.
Ability to learn various software programs.
Professional skills with an understanding of industry practices and company policies and procedures.
Developing proficiency with tools, systems, and procedures.
Good planning/ organizational skills and techniques.
Developing problem solving skills.
Good writing and communication skills.
Excellent conflict resolution skills.
Good decision making skills.
Excellent interpersonal skills.
Exercise judgment within defined procedures and practices to determine appropriate action.
Thorough understanding of regulations applicable to operations
General Knowledge of ISO

Nice To Haves

Previous medical device regulatory experience is desirable.
Typically hold 1 or more industry certifications.
Regulatory Affairs certificate is desirable.

Responsibilities

Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.
Implement and/or maintain systems and processes needed to ensure compliance with the receipt, storage and distribution of regulated products; as well as tracking distribution of prescription drugs and medical devices.
Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws.
Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.
Provide support during government inspections and audits, formulating the appropriate response and corrective actions.
Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities.
Provide cross functional support, including to other business units, researching issues pertaining to regulatory matters.Secure and maintain proper company licensure and product registration as needed.
Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
Participate in special projects and performs other duties as required.