Regulatory Specialist
2 weeks ago
Responsibilities:
- Candidate will be responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Responsible for technical writing of files in accordance with In Vitro Diagnostic medical 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.
Experience:
- 4+ years’ experience in Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements is required.
Preferred Experience:
- 1+ years’ experience in an IVD or medical device manufacturing environment.
Key Skills:
- Good knowledge of EU and international regulations.
- Good written & verbal communication skills;
- Strong time management skills, with the ability to work on multiple projects simultaneously;
- Proficiency with MS Office, including Word, Excel, PowerPoint and Visio
Must have:
- Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
- Strong knowledge of IVDR and EU regulatory requirements is required.
Education:
- B.S in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience
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