Position Summary:
Join Helavo, an innovative and dynamic team based in Germany, dedicated to enhancing the lives of our customers through high-quality mobility aids. We are currently seeking a Compliance Specialist to ensure our walking aids and rollators meet regulatory requirements and industry standards.
Key Responsibilities:
Regulatory Compliance: Ensure all products meet applicable regulatory requirements, including CE marking regulations, medical device directives, and other relevant standards.
Documentation Management: Maintain accurate records of compliance documentation, including technical files, risk assessments, and product labeling.
Quality Management: Implement and maintain quality management systems to ensure compliance with ISO 13485 standards and other quality regulations.
Product Testing and Validation: Coordinate product testing activities, including performance testing, biocompatibility testing, and clinical evaluations, to ensure compliance with regulatory requirements.
Risk Management: Conduct risk assessments and implement risk mitigation strategies to ensure product safety and compliance.
Regulatory Liaison: Serve as the primary point of contact for regulatory agencies and notified bodies, providing support for regulatory submissions and audits.
Continuous Improvement: Identify opportunities for process improvements and implement best practices to enhance compliance efficiency and effectiveness.
Qualifications:
Bachelor's degree in Regulatory Affairs, Quality Assurance, Biomedical Engineering, or related field; Master's degree preferred.
Minimum of 5 years of experience in regulatory compliance within the medical device industry, preferably with experience in mobility aids or related products.
Strong knowledge of European medical device regulations, including EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
Experience with quality management systems, including ISO 13485 certification and FDA regulations (preferred).
Familiarity with risk management processes, including ISO 14971 requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory authorities.
Detail-oriented mindset with strong analytical and problem-solving skills.
What We Offer:
Competitive salary and a diverse benefits package customized to your preferences and needs.
Friendly and highly professional working atmosphere in an international context.
Learning environment, support for proper onboarding.
A dynamic and professional working environment with multiple development opportunities
Work Equipment: MacBook Pro and Iphone if needed.
26 days Holiday
Work hybrid - 4 days at the office and 1 day remote