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 expectations and product claims.
Evaluate proposed device modifications to determine necessary regulatory actions
Support interactions with regulatory authorities by contributing to communication, tracking submission progress, and preparing required documentation.
Provide regulatory input on product labeling and claims, ensuring that clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
What you need:
Required:
Bachelors degree
Minimum of 3+ years of regulatory affairs experience within a regulated industry (e.g., medical devices, IVDs, pharmaceuticals, biotechnology, or healthcare products).
Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables.
Preferred:
Bachelors degree in Regulatory Science, or technical discipline (Engineering or Life Sciences)
Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout the product lifecycle.
RAC(s) certification
83,300.00 to 180,400.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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.