Regulatory & Compliance Manager

MAC Incorporated

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Regulatory & Compliance Manager Moorpark, California
Job Ref:
38125

REGULATORY & COMPLIANCE MANAGER OPENING MOORPARK CA DIRECT HIRE MUST COME OUT OF MEDICAL DEVICE NO OTHER INDUSTRY. 
nSALARY: $210-230k salary range 

nWill move fast!
nMust have ten (10) years industry experience in medical devices and/or a law degree  but atleast a BS Degree: Masters is preferred! 
nBilingual in Spanish language preferred
n
nTop 5 needed things:
n1. Medical Device Manufacturing Exp
n2. BS Degree or Masters preferred or Law Degree
n3. 5+ years' experience at least
n4. Compliance & Regulatory experience
nCandidate needs to be strong willed
nBilingual preferred
nAuditing Exp
nMust be aware of the Family dynamic as it is a family run business. Father is the CEO
nUK MDR & EU MDR (Medical Device Record) knowledge needed as they are expanding sales to Europe and the UK but are in the process of getting Certifications that this candidate will lead the company through.
nKnowledge of OSHA, GMP, ISO 13485 standards
nJob Description: Compliance & Regulatory Officer
nISO 13485:2016 certification pending. Will need to complete correction activities for last audit with nonconformities and complete a micro audit in Q2 of 2023.  
n
nExperience needed with the following:
n

    nt

  1. EU MDR for European Union states certification from scratch. Includes reading all new litigation. Begin 4/2023
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  3. UK MDR for the United Kingdom certification from scratch. Includes reading all new litigation. Begin 6/2023
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  5. Communication, correspondence and technical file review it European representative Emergo.
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  7. Management Review meetings quarterly each year.
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  9. Corrective and Preventative Actions (CAPAs) creation, remedy, verification of effectiveness and close out.
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  11. Complete an internal audit annually. Proper certification for Lead Auditor necessary to do so from a notified body such as BSI America.
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  13. In charge of Biocompatibility testing, sterilization validations, metal composition testing
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  15. Works closely with engineering for understanding of Design History Record (DHR) and Design Master Record (DHR) to maintain complete quality management system for compliance.
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  17. FDA GUDID– knowledge of how to list, what information is necessary for public record including Unique Device Identification system or UDI.
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  19. Risk Management protocols
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  21. Handle audits fort California Department of Public Health to maintain Medical Manufacturing License.
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  23. Handle audits for Waterboards.
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  25. Handle audits for Hazards for Ventura County.
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  27. All FDA correspondence and audits.
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  29. MedWatch reports
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  31. Post Market Surveillance
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  33. Investigate any complaints and quality issues.
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  35. OSHA
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  37. 510K application submittal and completion
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  39. Internal training for all new hires and existing employees on our standards of practice from our current Good Manufacturing Practices (cGMP) and Quality Manual.
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  41. Digital maintenance of QMS.
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n
nMust have ten (10) years industry experience in medical devices and/or a law degree  but atleast a BS Degree: Masters is preferred!  Bilingual in Spanish language preferred, but not necessary.
n ”

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