Supports global regulatory strategies and ongoing compliance for neurovascular medical devices. Responsibilities include evaluating product changes, identifying submission pathways, authoring FDA and international regulatory dossiers, interacting with regulatory agencies and notified bodies, reviewing labeling, monitoring regulatory intelligence, maintaining procedures, and advising cross-functional stakeholders across major global markets.
Work Flexibility: Remote
Travel Percentage: 20%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.
We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States.
As the Staff Regulatory Affairs Specialist, you will support Stryker’s neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.
What you will do
- Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
- Evaluate regulatory requirements and identify submission pathways for new products, ensuring alignment with applicable regulations.
- Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals.
- Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
- Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
- Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
- Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
- Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.
What you need
Required
Bachelor’s Degree (B.S. or B.A.)
Minimum 4 years of experience in an FDA-regulated industry
Minimum 2 years of experience in regulatory affairs
Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)
Preferred
Bachelor’s degree in engineering, science, or related field
Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
Experience with Class II or Class III medical devices
Experience authoring 510(k) submissions or equivalent regulatory filings
Experience interacting with regulatory agencies or supporting regulatory meetings
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
Travel Percentage: 20%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.
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