Senior Regulatory Affairs Specialist at Stryker - New Zealand

Greenwood Village, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Aug, 26

Salary

152700.0

Posted On

09 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Submissions, Compliance Management, Project Management, Regulatory Writing, Product Classification, Market Access, Regulatory Intelligence, Labeling and Claims Review, Stakeholder Management

Industry

Medical Equipment Manufacturing

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 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 United States of America Pay Ranges: US10: $91,600 - $152,700 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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Responsibilities

Develop and implement regulatory strategies to ensure compliance across the product lifecycle for Sports Medicine. Manage regulatory submissions and engage with authorities to support market access and resolve issues.