Regulatory Compliance Supervisor in Arden, NC at Medical Action Industries

Date Posted: 5/11/2018

Job Snapshot

Job Description

POSITION SUMMARY

 

Primary responsibilities will include managing supplier product recalls, and to assist with Regulatory Affairs, processes, functions & presentations. The incumbent must be well-versed in Food and Drug Administration (FDA), Quality System Regulation (QSR), and International Organization for Standardization (ISO) requirements. 

ESSENTIAL JOB FUNCTIONS:

1.      Manages supplier product recalls.

2.      Creates and maintains master files required for the Quality System Regulation.

3.      Organizes and maintains the regulatory filing systems.

4.      Assists with MAI Initiated product recalls.

5.      Assists with Corporate document and data control programs, processing work instructions, specifications and drawings.

6.      Assists with Change Control to Corporate guidelines and procedures.

7.      Assists with training to all company employees on Document Control/Change Control procedures.

8.      Final regulatory sign off for New Component Forms.

9.      Manages and maintains Material Safety Data Sheets (MSDS).

10.  Completes New Product Submission Forms and regulatory submissions.

11.  Researches Department of Transport (DOT) Regulations to ensure compliance.

12.  Completes Department of Transportation (DOT) surveys.

13.  Assists in regulatory audits such as FDA and ISO.

14.  Assists in regulatory projects and tasks as needed.

15.  Accurately complete necessary paperwork and reports.

16.  Manages, obtains and maintains necessary external standards and regulations.

17.  Assists in complaint handling process, investigations and trend analysis.

18.  Generates Returned Goods Authorizations and initiates call tag requests.

19.  Generates replacement product requests and credit requests.

20.  Assumes additional responsibilities as requested by immediate supervisor, other management personnel, or as business need dictates.

21.  Supervises the Quality Assurance Representatives.

22.  Manages the following:   Complaint Function and personnel; Document and Data Control; Document Change Control Process, and Master Label files.

SUPPLEMENTAL JOB FUNCTIONS:

1.      Performs additional duties as directed.



Qualifications

EDUCATION & EXPERIENCE REQUIRED:

  1. Associate Degree in a science discipline or a related field, and a minimum of 2-4 years of regulatory / quality systems experience, preferably in a manufacturing environment; or an equivalent combination of education and experience.
  2. Certification and / or Training of DOT Hazardous Materials a plus.
  3. Certification and / or Training of Quality System Regulations a plus.

KNOWLEDGE SKILLS & ABILITIES:

1.      Must possess a strong work ethic and a proven ability to work independently, make decisions and demonstrate good judgment.

2.      Requires the ability to work well in a team environment.

3.      Requires the ability to process and safeguard sensitive and confidential information.

4.      Must be able to operate standard office equipment.

5.      Willingness to attend educational workshops/seminars and review professional publications quarterly to maintain and increase professional/technical knowledge

6.      Ability to support the fiscal year inventory process.



Work Environment

 

EQUIPMENT, TOOLS & WORK AIDS

1.      Personal Computer

2.      MS Office Suite

WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS

1.      Inside working conditions.

2.      No environmental hazards indicated for this role.

3.      Ability to withstand varying temperature extremes in the warehouse is required to fulfill regularly assigned duties. 

4.      Must comply with company hygiene and gowning requirements as defined in the Department Operating Procedures, 'Gowning Requirements and Basic Hygiene for Warehouse, Assembly, Clean Room and Boxing Areas'.

5.      Must be able to withstand exposure to isopropyl alcohol used for hand cleaning.

6.      Must be able to withstand exposure to latex.

 

PHYSICAL REQUIREMENTS

1.      Fingering:   Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.

2.      Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.

3.      Sedentary work:  Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

4.      Visual Acuity:  Closely viewing in order to perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; inspection involving small defects, small parts and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

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