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intellectt is Hiring a Hiring _ Regulatory Specialist II _ Scarborough, ME - 04074 Near Scarborough, ME
device Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
- Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
- Researches and communicates scientific and regulatory information in order to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
- Develops internal procedures and tools. Conducts informational or training sessions for stakeholders. Organizes and maintains hard copy and electronic department files.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- 4 years’ experience in Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements is required.
Thanks & Regards,Kalyan K | Technical RecruiterEmail: Kalyan@intellectt.com
Direct: 1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Job Summary
Contractor
Business Services
$80k-104k (estimate)
05/30/2024
10/28/2024
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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