Regulatory Affairs Specialist in Fort Lauderdale, FL at Stryker Corporation

Date Posted: 9/22/2019

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 Robotics Division to be in Fort Lauderdale, FL.

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 support new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

  • Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Coordinate and assist in the preparation of submission packages for regulatory agencies
  • Assist in SOP development & review
  • Stay abreast of regulatory procedures and changes in regulatory climate
  • Investigate regulatory history of similar products to assess approval implications
  • Conduct research on submission requirements and options
  • Assist in monitoring and reporting project timelines
  • Assist with internal audits and inspections
  • Assist with collateral material review associated with new launches and ongoing product support

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline required.
  • Previous relevant working experience required.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents preferred.
  • Experience with international regulations preferred.
  • 510(k), IDE, PMA, CE Technical File/Design Dossier preparation, review, and submission experience or training preferred.
  • Experience interacting directly with FDA and Notified Body reviewers/inspectors preferred.
  • Understanding of the FDA device listing and establishment registration process preferred.
  • Complying with constantly changing regulatory procedures; reprioritizing work effectively.
  • Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.).
  • Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Must possess excellent oral and written communication skills.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Ability to communicate and network with regulatory personnel to obtain relevant information.
  • Excellent analytical and writing skills.

Work From Home: No

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.

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