Stryker

Senior Regulatory Affairs Specialist

Stryker

full-time

Posted on:

Location Type: Hybrid

Location: Flower Mound • Texas • United States

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Job Level

Senior

About the role

  • Support new product development and sustaining for both US and OUS global regulatory release through the development and execution of regulatory strategies.
  • Support the total product lifecycle by assessing changes made to the device post-launch to determine the regulatory impact of changes.
  • Ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies.
  • Evaluate engineering changes to existing products to determine regulatory impact.
  • Create and update regulatory deliverables as needed.
  • Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Evaluate proposed products for regulatory classification and jurisdiction.
  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory groups and others within the organization.
  • Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
  • Help train stakeholders on current and new regulatory requirements to ensure organization wide compliance.
  • Assist other departments in the development of SOPs to ensure regulatory compliance.
  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
  • Review collateral material associated with new launches and ongoing product support.

Requirements

  • Bachelor’s degree (B.S. or B.A.) required
  • 2+ years of working in an FDA regulated industry
  • 2+ years of medical device regulatory affairs experience
  • Previous experience with Class I and II Medical Devices
  • Bachelor's degree in Engineering, Biological Sciences or equivalent focus
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs or Engineering)
  • Previous experience with software Medical Devices
  • Experience interacting with regulatory agencies
  • Demonstrated success in management of global regulatory strategy and submission activities
  • Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)
  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategy developmentregulatory complianceregulatory documentationregulatory classificationSOP developmentregulatory impact assessmentmedical device regulationsglobal regulatory submissionsregulatory guidanceregulatory procedures
Soft Skills
problem-solvingcommunicationstakeholder traininginterdepartmental collaborationadvisory skillsanticipation of regulatory obstaclesadaptability to regulatory changesorganizational skillsattention to detailanalytical thinking
Certifications
RAC certificationMasters in Regulatory AffairsBachelor's degree in EngineeringBachelor's degree in Biological Sciences