Senior Regulatory Affairs Specialist in Cary, IL at Stryker Corporation

Date Posted: 10/1/2019

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 Senior Regulatory Affairs Specialist to join our Sage Division in Cary, Illinois.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • 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. 
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do

As a Senior Regulatory Specialist, you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products. This role is part of a growing and evolving Regulatory Affairs team that is focused on aligning and integrating to the Stryker global business.  The ideal candidate will have strong project management skills including the ability to communicate effectively to a diverse set of stakeholders.

In this role, you will be responsible, but not limited to the following:

  • Assessing the appropriate regulatory reporting mechanism using FDA and Health Canada regulations, guidance documents, and in-house policies upon review of Change Control Documentation.
  • Assessing and author amendments and supplements to product marketing applications.
  • Providing regulatory guidance to other departments for planned changes.
  • Providing a critical detailed review of technical documentation prior to health authority submission.
  • Compiling information and data pertaining to regulatory and project requirements including assessing needs; identifying the project’s critical factors; presenting decision-makers with options; and applying strategies.
  • Communicating with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions and follow-up on submissions in review. 
  • Serving as partner to marketing, engineering, clinical and quality on project and product development teams.
  • Improving awareness and visibility and communication on regulatory requirements to support company goals and priorities.
  • Operating with appreciable latitude for unreviewed action or decision.
  • Choosing the best alternative to achieve desired outcome or effect, giving consideration to timing, trade off, risks, and available resources.
  • Navigating the dynamics, alliances, and competing requirements of the business.

What you need

  • Bachelors degree in Engineering, Science or equivalent scientific area preferred
  • 3+ years of Regulatory Affairs experience
  • Must have medical device experience within US and Canada markets.
  • Strong preference for candidates with pharmaceutical experience.
  • Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing, and managing components of regulatory submissions is required
  • Team based work environment experience preferred with leadership of teams
  • Ability to understand and explain detailed regulatory compliance programs 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 judgement
  • Demonstrated analytical, writing and organizational skills
  • Demonstrated interpersonal, written and oral communication skills
  • Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs) preferred

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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