Regulatory Affairs Manager
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We are looking for a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for the strategic and operational planning and implementation of regulatory requirements in the field of active and non-active medical devices (Class I - IIb).
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Your main responsibilities will include:
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* Regulatory Strategy Development: Develop and implement regulatory strategies for medical devices, including compliance with the Medical Device Regulation (MDR) and international standards.
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* Technical Documentation: Create, maintain, and update technical documentation according to MDR and international standards, including risk management files, clinical evaluations, and user manuals.
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* Clinical Evaluation: Conduct clinical evaluations and post-market clinical follow-up (PMCF) activities for medical devices.
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* Risk Management: Identify, assess, and mitigate risks associated with medical devices.
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* Market Surveillance: Plan and conduct post-market surveillance (PMS) activities for medical devices.
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You will work closely with internal teams, such as product development, quality management, and marketing, to ensure compliance with regulatory requirements and ensure market authorization.
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Requirements:
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* Education: Bachelor's degree in natural sciences, engineering, pharmacy, or a related field.
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* Experience: Minimum 5 years of experience in regulatory affairs, preferably in the medical device industry.
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* Skills: Excellent knowledge of regulatory requirements, including MDR and FDA regulations.
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* Languages: Fluency in German and English.
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Benefits:
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* Competitive Salary: We offer a competitive salary and benefits package.
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* Opportunities for Growth: We provide opportunities for career growth and professional development.
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* Diverse Work Environment: We foster a diverse and inclusive work environment.
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* Flexible Working Hours: We offer flexible working hours and remote work options.
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About Us:
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We are a leading company in the healthcare industry, dedicated to providing innovative solutions for patients and customers worldwide. Our products and services are used in the treatment and care of critically ill and chronically patients.
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Why Join Us:
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We welcome applications from all qualified candidates, regardless of gender, age, origin, nationality, religion, disability, sexual identity, or orientation. We are an equal opportunities employer and strive to create a workplace that is inclusive and respectful of all individuals.
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Apply Now:
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If you are a motivated and experienced Regulatory Affairs Manager looking for a new challenge, please submit your application. We look forward to hearing from you!