Senior Regulatory Affairs Specialist
Vor 6 Tagen
SciPro is a pioneering company in the fight against skin cancer, expanding its innovative products across Europe, Australia, South Africa, and soon to be launched in the US market. To support this growth, they are seeking a highly skilled Quality Assurance Manager.
Key Responsibilities:- Maintain and oversee compliance with quality systems, ensuring seamless integration of regulatory requirements.
- Collaborate with authorities on regulatory submissions, leveraging expertise in FDA regulations (510k) and quality management systems (ISO 13485/21 CFR 820).
- Develop and implement training programs for staff on regulatory requirements, fostering a culture of compliance.
- Prioritize and manage audits and inspections, ensuring timely preparation and resolution of any issues.
- Oversee technical documentation for product submissions, guaranteeing accuracy and completeness.
- Bachelor's or Master's degree in engineering or biomedical sciences; an MBA is a plus.
- Minimum 3-5 years of experience in quality management and regulatory affairs for medical devices.
- Strong background in electrical standards (IEC 60601) and usability would be beneficial.
- Fluency in English is required.
This role presents a unique opportunity for a talented professional to make a significant impact in the medical device industry. If you possess the necessary skills and qualifications, please submit your CV to arrange a confidential conversation.
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