- This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, providing innovative solutions to transform treatment for patients suffering from mitral and tricuspid heart disease.
- This position within Medical Affairs (Contracts & Grants), will support the management and execution of contracts, budget and payments of educational and research grants, HCPs, educators, vendors, contractors, and consultants.
- Support contract lifecycle including negotiation, initiation, approval, payments, and documentation
- Assess needs for contract amendments and renewals, provide guidance to stakeholders, make recommendations, and negotiate changes to terms and conditions while mitigating risks to the company
- Subject matter expert for contracts, intent, and terms of agreement
- Manage educational and sponsorship grants payments
- Manage contracts and payments for research grants (investigator-initiated studies)
- Manage and administer Grant Portal via (SFDC)
- Manage educational grant repository and payment tracking system
- Track expenditure versus budget, support forecasting and generate metrics for reporting
- Identify and manage process improvement opportunities
- Identify and resolve problem through collaboration and alignment
- Partner with Legal, Compliance, Finance, and other cross-functional groups to ensure appropriate business practices
- Ensure strict compliance of processes and activities, and adherence to industry code of ethics
- Professional and customer-oriented interface with healthcare professionals and other entities
- Other duties as requested
- Bachelor's Degree or equivalent
- Experience working in healthcare and/or professional environment preferred
- 2+ years of experience required
- Proven expertise in Microsoft Office Suite, particularly Excel, PowerPoint, and Word
- Industry experience in medical device, pharmaceutical, biotech, or healthcare managing healthcare professional (HCP) contracts, compliance, budgets and/or payments
- Preferred Qualifications In addition to meeting minimum requirements, it would be nice to have the following:
- Cardiovascular medical device experience
- Experience with the following software or platforms: ECLM, Icertis, (SFDC), COUPA or similar payment systems
-
Specialist, Clinical Affairs
2 weeks ago
Jenavalve Technology Inc Irvine, United States**Job Title**: Specialist, Clinical Affairs · **Supervisor/Manager Title**:Senior** **Manager, Clinical Affairs · **Job Description Summary**:Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects. · **Responsibilities**: · - Provi ...
-
Specialist, Regulatory Affairs
1 week ago
Edwards Lifesciences Irvine, United StatesMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Regulatory Affairs Specialist, Selution
1 week ago
Cordis Irvine, United StatesOverview: · MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare worldwide. We specialize in the development, manufacturing, and commercialization of cutting-edge coronary and peripheral medica ...
-
Regulatory Affairs Specialist Temp
1 week ago
Nihon Kohden Irvine, United StatesThe Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team ...
-
Public Affairs Specialist
3 weeks ago
Orange County Sanitation District Fountain Valley, United States**Description**: · - What do **you **value in your next job? · At the **Orange County Sanitation District **our **Core Values **form the framework of our organization and reinforce our professional work ethic. If the following values ring true with you, we'd love to invite you to ...
-
Associate Regulatory Affairs Specialist
2 days ago
Medtronic Santa Ana, United States**Associate Regulatory Affairs Specialist (hybrid)** · Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains e ...
-
Regulatory Affairs Specialist
2 weeks ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional S ...
-
Regulatory Affairs Specialist
3 weeks ago
Tucker Parker Smith Group (TPS Group) Irvine, United StatesJob Title: Regulatory Affairs Specialist · Location: Irvine, CA · Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur · Duration: 1 year with potential to extend/ convert to internal FTE · no fully remote option · hourly rate of $40-45/hr · About Us: We a ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science Engineering Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
-
Regulatory Affairs Specialist
6 days ago
Brett Fisher Group - Search Consultants Irvine, United StatesThis is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, employees who find meaning in worki ...
-
Specialist, Regulatory Affairs
3 weeks ago
Edwards Lifesciences Irvine, United StatesMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Regulatory Affairs Specialist
2 weeks ago
MyKelly Irvine, United States Full timeRegulatory Affairs Specialist · The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provid ...
-
Regulatory Affairs Specialist
1 week ago
Brett Fisher Group Irvine, United StatesJob Description · Job DescriptionThis is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, em ...
-
graduate affairs specialist
14 hours ago
University Of California Irvine Irvine, United States· Job Opening ID: 69779 Reports To: Director of Graduate Studies Working Title: GRADUATE AFFAIRS SPECIALIST Department: SOM-Graduate Studies Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5, M-F Employee ...
-
Regulatory Affairs Specialist
3 weeks ago
Compunnel Irvine, United StatesJob Description: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · Create regulatory submissions (exercising judgment to protect proprietary information) for final ...
-
Regulatory Affairs Specialist
3 weeks ago
Motion Recruitment Irvine, United StatesOur client is seeking a motivated Regulatory Affairs Specialist. · The details are mentioned below: · Key Responsibilities: · • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track time ...
-
Regulatory Affairs Specialist
3 weeks ago
Nihon Kohden Irvine, United StatesThe Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organizations products. Work with RA Leadership and other members of the RA team t ...
-
Regulatory Affairs Specialist
1 week ago
Ledgent Technology Irvine, United States· Summary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · * Create regulatory submissions (exercising judgment to protect proprietary information) for finaliza ...
-
Regulatory Affairs Specialist
3 weeks ago
Trinus Irvine, United StatesJob Description · Job DescriptionSummary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · Create regulatory submissions (exercising judgment to protect proprieta ...
Medical Affairs Specialist - Irvine, United States - Intellectt Inc
Description
Job Description:
Key Responsibilities
Minimum Qualifications
Thanks & Regards
Pavani Chiluka
Recruitment Lead
Direct:
Office: ; Ext: 221
Intellectt Inc
#517 Route 1 South, Suite 1115 Iselin, NJ 08830.
--Email is the best way to reach me