Regulatory Affairs Specialist
1 month ago
Company Overview
Lifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields.
Job Title: Regulatory Affairs Manager
Salary: $120,000 - $180,000 per year
Location: Remote or On-Site (Flexible)
Job Description:
We are seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our medical device products comply with regional regulations and guidelines.
Your primary focus will be on maintaining a thorough understanding of new and existing regulations, standards, and guidelines that impact our organization's products and processes. You will collect, collate, and evaluate product-specific information to create and update dossiers for new product licenses and renewals.
You will also prepare submissions for regulatory registration and renewals, maintain data and files on country registrations, and collaborate with project teams to explain regulatory requirements, procedures, and policies.
Required Skills and Qualifications:
- Bachelor's degree in a technical or clinical field, such as engineering, medicine, or medical informatics
- 6-10 years of experience in regulatory affairs for medical devices, SaMD, SaaS, and cloud deployments
- Extensive knowledge of international laws, standards, and regulations for licensing medical devices
- Strong communication and interpersonal skills, with the ability to work in cross-functional teams
- Business-fluency in English, with knowledge of German an advantage
Benefits:
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are a motivated and experienced regulatory affairs professional looking for a new challenge, we encourage you to apply.
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