9 Regulatory Affairs Specialist II Jobs near me
Axelon Services Corporation is Hiring a Regulatory Affairs Specialist II Near Scarborough, ME
Location: Scarborough, ME
Shift: Mon - Fri | 8am to 5pm
RESPONSIBILITIES:
- 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 Client 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.
- Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
- 4 years' experience in Regulatory Affairs role.
- Strong knowledge of IVDR and EU regulatory requirements is required.
- 1 years' experience in an IVD or medical device manufacturing environment.
- Good knowledge of EU and international regulations.
- Demonstrated written and verbal communication skills.
- Strong time management skills, with the ability to work on multiple projects simultaneously.
- Ability to work independently as well as within a team.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
Job Summary
Full Time
$69k-90k (estimate)
05/07/2024
05/20/2024
axelon.com
New York, NY
500 - 1,000
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