Work Flexibility: Remote Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote) Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets. Work Flexibility: This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone What You Will Do Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities. Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases. Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies. Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals. Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance. Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities. Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications. Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory
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Role overview
Job description
As a Portfolio Manager on Stryker’s Knee team, you will help shape the future of the Partial Knee portfolio by identifying customer needs, supporting new product development, and building the business case for commercialization. You’ll leverage research, market intelligence, and cross-functional collaboration to bring forward-thinking strategies to life and support our mission of moving patient lives.
What you will do:
- Develop portfolio and product strategies by translating customer, patient, and market insights into compelling value propositions and growth opportunities.
- Leverage qualitative and quantitative market research, Voice of Customer (VOC), competitive intelligence, and third-party data to identify customer needs, industry trends, and market opportunities.
- Partner cross-functionally throughout the New Product Development (NPD) process, helping advance new products from concept through commercialization.
- Build financial business cases and ROI models to evaluate new product opportunities and support investment decisions.
- Develop market assessments, volume forecasts, and commercialization strategies grounded in market dynamics, customer insights, risk, and uncertainty.
- Partner with Product Marketing to develop go-to-market and product launch strategies for new products.
- Identify opportunities for customer acquisition, retention, market expansion, and portfolio growth, evaluating the financial tradeoffs associated with each.
- Partner with Clinical Affairs and Product Marketing to develop clinical evidence, publication, and messaging strategies that support portfolio objectives.
- Lead Product Lifecycle Management (PLCM) activities aligned with the broader portfolio and business strategy.
- Develop pricing strategies aligned with market dynamics, customer value, brand positioning, and overall marketing strategy.
- Support development of sales enablement tools, marketing channels, and commercial communications that drive product adoption.
- Build strong cross-functional partnerships across Marketing, R&D, Clinical Affairs, Finance, Sales, and other key functions to achieve portfolio objectives.
What you will need:
Required:
- Bachelor’s degree required.
- 4+ years of work experience required.
Preferred:
- MBA preferred.
- 2+ years of medical device or marketing experience preferred.
- Excellent presentation and interpersonal communication skills.
United States of America Pay Ranges:
- US20: $107,200 - $178,600 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 30%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.
What they are looking for
Skills & requirements
Qualification
What you will need: Required: Bachelor’s degree required; Preferred: MBA preferred; 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
Hiring company
Stryker
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