Senior Regulatory Affairs Specialist

Job description

Work Flexibility: Hybrid or Onsite Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO ! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access. What you will do: Develop and update regulatory strategies at the local, regional, and global levels by monitoring regulatory intelligence and emerging requirements. Determine product classification, submission requirements, and approval pathways, preparing and submitting regulatory filings in alignment with applicable guidelines. Assess the regulatory landscape and provide guidance across the product lifecycle to support compliant development, manufacturing, and commercialization. Identify potential regulatory obstacles, anticipate upcoming issues, and recommend practical solutions to maintain compliance and support market access. Review quality, preclinical, and clinical documentation to ensure readiness for regulatory submissions and consistency with regulatory expectation...