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Regulatory Affairs Intern in Tempe, AZ at Stryker Corporation

Date Posted: 2/13/2019

Job Snapshot

Job Description

Summary

The Regulatory Affairs Intern manages the regulatory issues associated with commercialization of medical devices.

Essential Duties and Responsibilities

The Regulatory Affairs Associate will have primary responsibility for managing the regulatory issues associated with commercialization of medical devices, including but not limited to:

  • Preparing pre-market technical submissions, including establishing and maintaining necessary written procedures, such as for submission review and approval, and review of the significance of device modification to regulatory bodies such as the FDA;
  • Participating in new product development teams, especially as required by Design Control procedures, process assessments and improvements;
  • Interfacing with key staff members in strategic planning, gap analysis, product development, operations, and customer service departments to meet scheduled submission dates;
  • Maintaining cordial relations with counterparts and officials in federal and state government regulatory agencies, FDA liaison;
  • Evaluating data generation carefully in line with scientific principles and company policies. Review line extensions, marketing, materials, and protocol reports. Reviews and edits materials to meet regulatory requirements and company policy.
  • Participating in the development of product labels and labeling, particularly Instruction for Use documents, package labels, sales and marketing literature and presentation reviews/approvals, as well as web-based marketing claims, including necessary written procedures;
  • Participating in activities of the Association of Medical Device Reprocessors in reviewing and responding to FDA proposals for regulation of medical device reprocessing;
  • Participating in Risk Analysis as part of Cross Functional Teams;
  • Conducting OEM Change Monitoring;
  • Performing recalls and sub-recalls;
  • Responding to Customer/Sales representative questions and issues;
  • Advising department manager when significant deviations occur from planned submission schedule or when testing or labeling will be unlikely to meet regulatory requirements, compliance issues.

Supervisory Responsibilities

  • None

Qualifications

  • Ability to manage the regulatory functions, as well as involvement in key projects.
  • Ability to interface with both technical and non-technical personnel
  • Possesses excellent interpersonal, analytic, and problem-solving skills.
  • Possesses strong interpersonal and persuasive skills.

Education and/or Experience

  • A Bachelor’s degree, preferred.
  • 1-2 years experience in regulatory areas.
  • Experience with FDA regulations and compliance, preferred.
  • QA/Reg experience in class II medical devices, preferred.
  •  Expertise with 510(k) submissions, preferred

Computer Skills

  • Proficient in Microsoft Word, Excel, Power Point, Outlook
  • Internet

Work Environment

  • Office
  • Production / Cleanroom at times
  • While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
  • The employee may occasionally lift and/or move up to 25 pounds.
  • The noise level in the work environment is usually moderate.
  • May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.
  • Required at times to wear Personal Protective Equipment to protect against exposure to Bloodborne Pathogens and chemicals.
  • Travel 10%.

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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