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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 

January 15, 2020

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Regulatory/Compliance Specialist

December 26, 2019


McCord Executive Search is working in partnership with longtime client company as they are seeking a Regulatory and Compliance Specialist to support new product development and production facilities. The role will support continued growth of the company’s regulatory service offerings and customer requirements.  Job location is open to either Hudson or Menomonie, WI - I have first hand knowledge of this client so give me a call to learn more how you can get in the door.
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


NOTE: This position does not qualify for VISA sponsorship


Send your resume to sharon@mccordexecutivesearch.com



















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