Compliance Manager
Shirley, NY  / Irvine, CA 
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Posted 28 days ago
Job Description
Description

Responsibilities:

  1. Develop and implement processes to ensure compliance of all departments as related to business compliance activities. Helps to establish acceptance criteria and verify compliance to regulatory compliance to (GMP/FDA/ISO/MDD/MDR/ROHS/REECH/UDI/Calibration, certificates, labeling, etc.)
  2. Continually reviews federal, international, and specific country regulations and regulatory agencies to ensure compliance and to notify Management in changes to regulations that will impact site operations
  3. Administration of Export Control Policies and Processes
  4. Administration of Compliance systems, procedures, and policies. Helps management team with providing guidance on compliance requirements as related to any products, processes, or projects
  5. Administration of compliance related requests from an internal and external perspective
  6. Administration of all compliance related spreadsheets and processes
  7. Continuous review of all products, systems, and processes to ensure continued adherence to compliance requirements (Internal and External)
  8. Cross functional team member that interacts with all departments to ensure that any identified compliance risks are mitigated in a timely manner
  9. Administration of compliance documentation and files. Work with marketing and sales teams to ensure accurate compliance documentation is posted on the company website
  10. Provides support for regulatory/compliance elements for the technical files and tollgates
  11. Supports the Quality Function during internal or external audits as required
  12. Continually reviews the compliance landscape to ensure awareness around regulation and compliance changes
  13. Ensures timely filing of any compliance documents that are required internally or externally

Attendance: Must meet attendance requirements

Skill Requirements: External Lead Auditor Certification (Preferred)

Remote work options are available

Authority:

This position has the authority to discontinue the use of suspect components or materials and cease the shipping of finished goods if there is any failure in meeting compliance requirements. These actions will immediately be brought to the attention of the Site Leader or most appropriate Senior Management Officer.

Physical Requirements/Job Hazards: May be required to handle heavy products

Qualifications

Experience
Experience in using procedures and standards to keep business in compliance (preferred)
Supervisory responsibilities include helping the Operations Production Manager to plan and direct the work activities for employees involved with business compliance (preferred)
5 years: Medical Device/Quality Control field preferred with supervisory role (preferred)
5 years: Supervisory Experience (required)


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

AAP/EEO Statement- Mirion Technologies, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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