Regulatory Affairs Specialist

Job Description

Job Description

Objective

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.

Essential Duties and Responsibilities

Typically responsible for two or more of the following duties.

1. 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.

2. 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.

3. Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws.
4. Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.
5. Provide support during government inspections and audits, formulating the appropriate response and corrective actions.
6. Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities.
7. 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.
8. Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
9. Participate in special projects and performs other duties as required.

Supervisory Responsibilities

This position has no supervisory responsibilities.

Education and/or Experience

Typically a Bachelor's degree (B.A./B.S.) from four-year college or university in a scientific field; and 2 - 4 years related professional experience; or equivalent combination of education and experience. Previous medical device regulatory experience is desirable. Typically hold 1 or more industry certifications.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Language Skills

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.

Mathematical Skills

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Computer Skills

Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Certificates, Licenses, Registrations

Regulatory Affairs certificate is desirable. Typically hold 1 or more industry certifications.

Knowledge, Skills, and Abilities

· 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.

SPECIFIC KNOWLEDGE & SKILLS:

· Thorough understanding of regulations applicable to operations

· General Knowledge of ISO

Physical Demands and Work Environment

Travel typically 10% to 20%. Office environment. No special physical demands required.

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to stand, walk, sit, talk, hear, and use hands repetitively. The employee is occasionally required to use hands to finger, handle, or to feel; to use hands to grasp; to use extended reach with hands; to use fine dexterity with both hands; and lift or move up to 10 lbs. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet.

The posted range for this position is $66,500-$90,802 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

DenMat offers a complete benefits package, including medical/dental/vision/Rx, Life, 401(k) with matching, 10 paid company holidays, vacation and sick time, bereavement, EAP, and employee discounts.

DenMat participates in E-Verify.

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.