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 of5 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
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