Medical Device Regulatory Affairs Strategist
Oracle
Medical Device Regulatory Affairs Strategist
Job Description
Overview
As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable.
Locations
- United States, United States
Salary
Responsibilities
- Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device)
- Help prepare the required documentation to register products in global markets where the products are sold
- Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope
- Work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: Flexible PTO
Answer 10 quick questions to check your fit for Medical Device Regulatory Affairs Strategist @ Oracle.
Related Books and Jobs
Medical Device Regulatory Affairs Strategist
Oracle
Medical Device Regulatory Affairs Strategist
Job Description
Overview
As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable.
Locations
- United States, United States
Salary
Responsibilities
- Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device)
- Help prepare the required documentation to register products in global markets where the products are sold
- Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope
- Work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: Flexible PTO
Answer 10 quick questions to check your fit for Medical Device Regulatory Affairs Strategist @ Oracle.
Related Books and Jobs