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Senior Regulatory Affairs Specialist

2 months ago

Cary, Illinois, United States Stryker Full time

Work Flexibility:

Hybrid. Stryker is recognized as a premier medical technology firm, committed to enhancing healthcare in collaboration with its clients.

The organization provides cutting-edge products and services across Medical and Surgical, Neurotechnology, Orthopaedics, and Spine sectors, aiming to elevate patient and healthcare outcomes.

Together with its global partners, Stryker positively influences over 130 million patients each year.

We are currently in search of a Senior Regulatory Affairs Specialist (Pharmaceutical Products) to become part of our Medical Division.

This position offers a hybrid work environment based in Cary, IL. Who we seek:
  • Detail-oriented Process Innovators: Individuals who possess a keen eye for detail and can identify opportunities to enhance and streamline work processes.
  • Collaborative Team Players: Professionals who excel in building and utilizing cross-functional relationships to amalgamate ideas, insights, use cases, and industry analyses to formulate best practices.
  • Business-focused Analysts: Individuals who can interpret data effectively to illustrate the impacts of business initiatives, regulations, and industry trends for various teams.
Key Responsibilities:

As the Senior Regulatory Affairs Specialist, your role will involve providing critical information to assess proposed products for regulatory classification and jurisdiction.

You will conduct thorough research on requirements (local, national, international), relevant guidance, standards, and regulatory submission options, including approval pathways and compliance activities.

  • Prepare and author FDA-required Annual Reports for New Drug Applications.
  • Evaluate the suitable regulatory reporting mechanisms based on FDA regulations, guidance documents, and internal policies after reviewing Change Control Documentation.
  • Assess and draft amendments and supplements to product marketing applications.
  • Offer regulatory guidance to other departments for anticipated changes.
  • Conduct a meticulous review of technical documentation prior to FDA submission.
  • Compile and analyze information regarding regulatory and project requirements, identifying critical factors and presenting options to decision-makers.
  • Engage with regulatory agencies concerning pre-submission strategies, regulatory pathway development, submissions, and follow-ups on submissions under review.
  • Collaborate with marketing, engineering, clinical, and quality teams on project and product development initiatives.
  • Enhance awareness and communication regarding regulatory requirements to align with company objectives.
Qualifications:

A minimum of a Bachelor's Degree (B.S. or B.A.) in Science, Engineering, or a related field is required.

At least 4 years of experience in an FDA-regulated industry is essential, preferably within pharmaceuticals and medical devices.

A minimum of 2-3 years in a Regulatory Affairs capacity is necessary. RAC certification or an Advanced Degree (Master's in Regulatory Affairs) is preferred.

Experience in authoring regulatory submissions for product approval is advantageous, as is experience in interacting with regulatory agencies.

Candidates must demonstrate the ability to adapt to evolving regulatory procedures and prioritize tasks effectively.

Strong analytical and writing skills, along with excellent interpersonal, written, and verbal communication abilities, are crucial.

Effective organizational skills and advanced proficiency in Microsoft Office Suite, including Excel, are required.



Travel Percentage:
0%. 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.