Job description
CANDIDATE WILL START AS SOON AS SELECTED AND HAS CLEARED ONBOARDING.
POSITION IS 1 YEAR FROM START DATE WITH POSSIBLE EXTENSIONS.
HYBRID SCHEDULE ~ 3 ONSITE IN OFFICE WITH 2 DAYS REMOTE OR AT HOME
ROLES/RESPONSIBILITIES
This contract position works out of our Alameda, CA, location, supporting our Client Care (ADC) division. This regulatory support position will monitor trends from companies and regulatory agencies related to diabetes to provide regulatory intelligence to ADC. The role will provide regulatory analysis for medical/non-medical device applications, monitor digital health trends, and contribute to regulatory strategy through regulatory intelligence. This position will also develop and lead a program that monitors the medical device supply for potential regulatory reporting requirements. Lastly, this position will also support necessary regulatory activities required for product market entry.
REGULATORY INTELLIGENCE [Primary responsibility]:
- Execute a successful U.S. regulatory intelligence program
- Carry out surveillance to help inform ADC regulatory strategy
- Develop and maintain list of regulatory inputs to monitor
- Continuously seek to add and refine the regulatory inputs list to remain relevant for ADC business objectives
- Execute searches of regulatory inputs on defined intervals (e.g. daily and weekly searches) to assist ADC in awareness of relevant information in a timely manner
- Support ad hoc regulatory intelligence requests from within RA and from other ADC functional groups
- Develop and foster relationship with ADC Competitive Intelligence
- Host quarterly cross-functional meetings to share regulatory intelligence across ADC
- Participate in monthly meetings with other ADC RA groups with regulatory/competitive intelligence teams to share across ADC RA
- 506J:Assist in SOP development, review and execution for a medical device supply monitoring program for potential regulatory report requirements [Responsibility only active during an official U.S. Public Health Emergency].
- Execute and document regular reviews of product supply status with Supply/Demand Planning.
- Support 506J notifications as required per ADC process.
- Communicate to AQR and to other ADC business units any alterations in ADC’s 506J process, or communications from FDA related to 506J reporting.
NEW PRODUCT INTRODUCTION SUPPORT: Support regulatory activities for new product introductions
- Compile, prepare, review and submit regulatory submission to authorities.
- Reviews protocols and reports to support regulatory submissions.
Job Requirements
- Bachelor’s degree is required (or) equivalent.
- 2 to 4 years of U.S. regulatory affairs experience within medical devices is preferred.
Skills Expected for Role
- Writing skills
- Decision-making skills
- Problem-solving; inquisitive
- Presentation skills
- Technical Skills
- Excel
- Power point
- Word
- Outlook – Email
Job Type: Contract
Salary: $30.72 - $35.00 per hour
Benefits:
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Saint Paul, MN 55117: Reliably commute or planning to relocate before starting work (Required)
Education:
- Bachelor's (Preferred)
Experience:
- medical devices: 2 years (Preferred)
- regulatory affairs: 2 years (Preferred)
- regulatory submissions: 2 years (Preferred)
- Reviews protocols and reports: 2 years (Preferred)
Work Location: One location
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