Regulatory Affairs Professional
Salary/Rate:€60,000 - €70,000 DOE
Job type:Perm
Town/City:Freiburg
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:25406
Post Date:27. 08. 2024
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About the Role
Regulatory Affairs Professional
Location: Freiburg, hybrid flexibility
Are you ready to ensure groundbreaking medical products reach global markets by navigating regulatory challenges?
As a Regulatory Affairs Professional, you will play a critical role in ensuring that IVD products meet all regulatory requirements for international markets. Collaborating closely with the quality management team, you will develop and implement approval strategies, prepare and submit regulatory documentation, and act as a key contact for regulatory authorities.
Your tasks:
What is required:
What is offered:
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
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If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
#LI-Hybrid
Location: Freiburg, hybrid flexibility
Are you ready to ensure groundbreaking medical products reach global markets by navigating regulatory challenges?
As a Regulatory Affairs Professional, you will play a critical role in ensuring that IVD products meet all regulatory requirements for international markets. Collaborating closely with the quality management team, you will develop and implement approval strategies, prepare and submit regulatory documentation, and act as a key contact for regulatory authorities.
Your tasks:
- Develop and implement regulatory strategies in collaboration with quality management.
- Stay updated on regulatory changes and ensure compliance with international norms and standards.
- Prepare, review, and adapt approval-relevant documents, including technical documentation.
- Submit marketing authorization documents and manage product registrations with relevant authorities.
- Monitor and maintain compliance with applicable norms and standards.
- Initiate corrective and preventive actions in response to quality-related issues.
What is required:
- A university degree or relevant professional experience (2+ years) in Regulatory Affairs.
- In-depth knowledge of IVDR and IVDD, with familiarity with other international regulations and approval procedures.
- Fluency in both German and English, with excellent written and verbal communication skills.
- Strong attention to detail and quality awareness.
What is offered:
- Flexible working hours and mobile working options.
- Ongoing training and personal development opportunities with a dedicated training budget.
- Regular team events and a supportive, motivated team environment.
- A dynamic work environment where you can actively contribute to shaping the company's structure and goals.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
- Expert advice on your CV and cover letter
- Guidance on salary expectations
- Personalized interview preparation
- Connections to exclusive job opportunities
- Assistance in negotiating the best possible offers
- 50% of the CVs we send to clients are accepted
- Accepted or declined, either way we will provide you with feedback
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
???????
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
#LI-DW1
#LI-Hybrid