Senior Regulatory Affairs Specialist in Cary, IL at Stryker Corporation

Date Posted: 2/11/2020

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 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. 
  • 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:

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
  • Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Evaluates proposed products for regulatory classification and jurisdiction
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
  • Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Assists other departments in the development of SOPs to ensure regulatory compliance
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
  • Provides regulatory information and guidance for proposed product claims/labeling
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

  • Bachelors degree in Engineering, Science or equivalent scientific area preferred
  • 3+ years of Regulatory Affairs experience
  • Strong preference for candidates with pharmaceutical or medical device experience.
  • Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing, and managing components of regulatory submissions preferred
  • 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: 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.

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