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About McCord Executive Search

McCord Executive Search, LLC provides direct placement and contract staffing with manufacturing companies, specializing in Engineering, Manufacturing Management, and Director level search, offering both retained and contingency. Industries - Medical Device, Plastics, Food Manufacturing, and Industrial/Advanced Manufacturing. 

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Phone: 651-301-1904

Email: sharon@mccordexecutivesearch.com 

December 5, 2019

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Regulatory/Compliance Specialist

December 4, 2019

As Regulatory and Compliance Specialist you will support new product development and production facilities. The role will support continued growth of the company’s regulatory service offerings and customer requirements.
Essential Functions:

  • Act as core team member of RA/QA for project development life cycle.

  • Maintain State and Federal License renewals and annual registrations.

  • Coordinate with Notified Bodies, Competent Authorities and other regulatory agencies on submissions, audits, approvals or other issues

  • Ensure information relevant is available to customer submissions via Drug Master Files (DMF) or Device Master Files (MAF)

  • Develops regulatory strategy for difficult issues which could significantly impact project timelines and costs

  • Development, implementation and maintenance of regulatory SOP’s and development/improvement of processes and procedures

  • Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle. 

  • Responsible for creating Clinical Evaluation Reports as needed

  • Performs compliance auditing activities.

  • Some programs may have vision requirements

Required Qualifications:

  • BS/BA in science, engineering, business, quality/regulatory degree; Masters or industry qualification in Regulatory Affairs desirable.

  • Minimum 5 years’ experience in regulatory affairs within the Medical Device/Pharma industry

  • Knowledge of applicable international regulations and standards (CFR, MDD/MDR, QSR, ISO 13485, CMDCAS, etc.) preferred

  • Good knowledge of product development and processes

  • Experience with regulatory audits and inspections

  • Technical report writing skills


 Skills and Abilities:

  • Leadership skills including ability to maintain confidentiality

  • Decision making and prioritization skills

  • Strong written, verbal and interpersonal communication skills with the ability to influence outcomes

  • Strong organizational skills with high attention to detail

  • Excellent team player, with ability to get along with colleagues and work as part of a team

  • Problem solving skills

  • Flexible attitude to work - ability to adapt to changing demands and requirements

This position does not qualify for VISA sponsorship


For further details of job location, company, send your resume for immediate consideration to sharon@mccordexecutivesearch.com











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