Manager Regulatory Affairs
Posted on :
21-09-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
21-09-2024
Job Description
This role is for one of the Weekdays clients
What You ll Do:
As a Manager of Regulatory Affairs youll oversee regulatory activities for our medical products. Your responsibilities include:
- Ensuring compliance with regulatory requirements during product design development production and postmarket surveillance.
- Independently applying standards and regulations to our products and processes.
- Registering medical devices globally with a focus on EU and US markets.
What You Bring:
- A completed education in natural sciences law medical technology or a similar field.
- Experience in Regulatory Affairs preferably with IEC 60601 or IEC 62304 standards.
- Strong ability to work independently and in teams and effectively communicate with authorities.
- A proactive approach to improving processes and adapting to company culture.
- Passion for navigating the regulatory landscape in medical technology and confidence in engaging with authorities like the FDA.
- Fluent English and German (or willingness to learn German).
regulatory affairs,iec,medical technology,process improvement,iec 60601,german language,fda,communication,compliance,iec 62304,medical products
Employment Type
Full Time
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
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