Principal Specialist, International RA
Share
Job Location:
San Jose, CA - USA
Monthly Salary:
$ 126500 - 273900
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Principal Specialist International RA
Locations: San Jose CA / Flower Mound TX / Denver CO
At Stryker regulatory excellence enables innovation that saves and improves lives. As a Principal Specialist in International Regulatory Affairs you will shape global regulatory strategies that accelerate access to medical technologies while protecting patients and communities worldwide. This is a highly visible role where strategic thinking global impact and regulatory leadership come together.
Work Flexibility:
Hybrid must reside within a commutable distance to one of the listed Stryker facilities and work onsite several times per week.
What You Will Do
- Develop and maintain global regional and multicountry regulatory strategies aligned with business and product lifecycle objectives to achieve timely market access.
- Evaluate global regulatory trends stakeholder expectations and evolving requirements to inform longrange regulatory planning and risk mitigation.
- Identify regulatory pathways for new and existing product designs; assess adequacy of proposed strategies and recommend refinements based on regulatory outcomes.
- Guide crossfunctional teams on regulatory considerations for product entry exit labeling claims and data requirements ensuring submission readiness.
- Lead negotiations and sustained interactions with regulatory authorities across development approval and postapproval phases to resolve complex issues.
- Assess regulatory impacts of clinical preclinical and manufacturing changes and determine submission or nonsubmission approaches.
- Oversee preparation and approval of highquality electronic and paper regulatory submissions to achieve ontime global filings.
- Prepare teams for regulatory inspections audits advisory panels and authority meetings supporting successful outcomes and renewals.
What You Will Need
Required
- Bachelors degree in Engineering Science or a related field.
- 8 years of professional experience including work in medical device regulatory affairs or a closely related field.
Preferred
- Masters degree in Regulatory Science or related field.
- Regulatory Affairs Certification (RAC).
- Experience developing global multicountry regulatory strategies for devices addressing serious or lifethreatening conditions or unmet needs.
$126500 - $273900 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Travel Percentage: 0%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 contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Business Development
- Classroom Experience
- Dayforce
- Go
- Cloud Computing
- AWS
- Teaching
- Administrative Experience
- Leadership Experience
- negotiation
- SAS
- Data Analysis Skills
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
