4 Jobs in Alameda, CA
intellectt is Hiring a Regulatory Affairs Associate Near Alameda, CA
I Hope you are doing great.
This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Associate - Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com
Role: Regulatory Affairs AssociateLocation: Alameda, CA Duration: 12 Months Shift Timings: 8 AM to 5 PM PST Job Description
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 5-8 years of direct experience in the field.
- Recent experience with Class III implantable medical devices;
- Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
- knowledge of FDA PMA guidance documents and CFR regulations.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a unit/department.
Ajay BhanuIntellectt Inc
Direct: 732 784 4384Desk number : 732 412 6999- Ext: 159
517 Route 1 South, Suite 1115 Iselin, NJ 08830
WhatsApp: https://chatwith.io/s/bhanu
Job Summary
Contractor
Business Services
$74k-97k (estimate)
05/09/2023
10/02/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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The following is the career advancement route for Regulatory Affairs Associate positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Associate, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Associate. You can explore the career advancement for a Regulatory Affairs Associate below and select your interested title to get hiring information.
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