Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Manager, Medical Safety to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere in United States.
Stryker's Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to "Make Stroke History". Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: [ Link removed ]
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
Insightful advisors. Managers who lead strategy development and provide guidance to teams.
What you will do
As the Senior Manager, Medical Safety you will be delivering to department vision and goals, you will serve as the department leader for Global Medical Safety. You will manage a team of 4-6 individuals and maintain responsibility for managing medical safety deliverables across business franchises (Flow Diversion, Stents/Coils and AIS). You will work with confidential company data and interface with cross-functional internal and external stakeholders. You will contribute towards clinical trial and risk assessment deliverables per company SOP's and ensuring compliance to regulations related to safety reporting requirements. You will represent Stryker Neurovascular as the Medical Safety subject matter expert for the Neurovascular product portfolio developing and maintaining in-depth therapeutic and product knowledge, and knowledge regarding product safety including risk assessments, post market surveillance and assessing product non-conformities and health hazard evaluations.
Recruit, onboard, train and manage talent for building organizational capabilities.
Manage a team of 4-6 individuals.
Create efficient business processes, procedures and templates contributing to building Medical Safety
Manage Medical Safety deliverables, including Clinical (creation of safety and complaint plans, review and triage of Adverse Events and Device Deficiencies, establishing Safety Monitoring Committees- CEC and DSMB, Contributing to Protocol's, CSR, Interim and Final Reports); Risk Assessments (FMEA's, CER's, CEP's), Post Market Surveillance (Complaint Review, PMSR's, Signal Detections, NC's, HHE's).
Manage resource allocation, budget accruals and department key performance indicators.
May author integrated safety summaries from raw data.
Ensure trending of safety data is conducted per Safety Plans.
Provide Medical Safety subject matter expertise and consultation, as needed to Design Quality Assurance, Program Managers, Clinical Services, Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Science, Complaints Team and other internal and external stakeholders.
Collaborate with other department heads to resolve complex or unclear situations.
Responsible for staff training plans.
What you need
A minimum of a Bachelor's Degree is required or equivalent in health care field (RN, BSN, MBBS, DPharm) is required.
A MD, NP, PhD in Biological or Life Sciences, or Master's in Public Health preferred.
A minimum of 10 years in a clinical research or health-related field required.
A minimum of 3 years of Safety experience required.
Previous experience in people management or leadership capacity required.
Demonstrated work experience to Recruit, Manage, Coach, Mentor and Develop talent for the organization preferred.
Experience in IDE / Class III products/ clinical trials preferred.
Vascular experience preferred.
Medical device industry experience required.
Work From Home: Remote
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
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.