Regulatory Affairs Specialist in Tempe, AZ at Stryker Corporation

Date Posted: 10/30/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Regulatory Affairs Specialist to join our Sustainability Solutions Division to be based in Tempe, AZ.

Who we want

  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality. 

What you will do

As the Regulatory Affairs Specialist, you will be involved with the regulatory practices associated with commercialization of medical devices.

  • Address and advise teams on appropriate pathways to market under the supervision of more experienced regulatory professionals.

  • Participate on product development and sustaining engineering teams to insure appropriate global regulatory requirements are incorporated as part of the development and design change process.

  • Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.

  • Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers; review and approve document action requests.

  • Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues under the supervision of more experienced regulatory professionals.

  • Establish and maintain regulatory information systems both electronically and hard copy.

  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.

  • Conduct labeling, marketing, product transfer and literature review pre and post market under the supervision of a more experienced regulatory professional.

  • Assist the RA Managers and others with the development, implementation and maintenance of regulatory SOP's.

  • Interface with key staff members in strategic planning, product development, operations, and customer service departments to meet scheduled submission dates.

  • Stay at the forefront of evolving Regulatory Standards and able to research multiple diverse databases to compile data, document appropriately and submit in a timely fashion keeping in mind often shifting priorities due to business needs.

What you need

  • A Bachelor’s Degree (B.S or B.A) required; Engineering or Science focus preferred.

  • Previous experience with Medical Devices, Regulatory Affairs, Quality or Engineering required.

  • Experience within a Regulatory Affairs, Quality or Engineering role preferred.

  • Excellent interpersonal, written English and oral communication skills.

  • Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint.

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

  • Excellent organizational, problem-solving, and analytical and time management skills.

  • Ability to interface with both technical and non-technical personnel at all organizational levels.

  • Technical writing experience preferred.

  • Regulatory Affairs Certification (RAC) preferred.

Work From Home: Occasional

Travel Percentage: 10%

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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team