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Regulatory Affairs Specialist – Customer Quality in Portage, MI at Stryker Corporation

Date Posted: 12/3/2018

Job Snapshot

Job Description

The Regulatory Affairs Specialist, Customer Quality -- to be based in Kalamazoo, Michigan -- will be responsible for: determining reportability to the appropriate medical device authority for events that either contributed or could have contributed to adverse events; reviewing and approving investigations and closure of product inquiries; and reviewing and approving of team members' reportability decisions.

Essential Functions:

  • Review and approve investigations
  • Review complaints and assess them for regulatory reporting (US <30 days, International agencies as appropriate to the regulations)
  • Handle all necessary complaint handling process activities
  • Submit initial and follow-up reports to device related Agencies as needed
  • Interact with device related Agencies on vigilance reports and incidents globally
  • Work with quality investigators on gathering information for reportability decisions
  • Utilize Corporate and Division procedures
  • Assist with training other departments on their complaint handling and reporting responsibilities
  • May review Ambulance Accident Evaluations and provide communication support to customers regarding policy and process
  • Prepare and support internal and external audits

Qualifications:

  • Bachelor’s degree
  • Excellent interpersonal skills
  • Excellent written and oral communication. Ability to interface with both technical and non-technical personnel at all organizational levels
  • Excellent organizational, problem-solving, attention to detail, analytical, and time management skills
  • Knowledge of applicable and international regulations and standards preferred
  • 1-2 years experience in medical devices, biologics and/or pharmaceutical field desired (preferred)
  • Training and/or certifications in regulatory affairs preferred

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation 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.

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