Head Of Quality And Regulatory Affairs
vor 2 Wochen
Our client is an innovative leader in the MedTech industry, dedicated to transforming the planning of cardiac interventions through cutting-edge software solutions. Their mission is to enhance the precision and effectiveness of minimally invasive cardiac procedures, thereby improving patient outcomes globally. With strong partnerships with leading medical institutions and backing from prominent investors, the company is well-positioned for significant growth and impact.
The Head of Regulatory and Quality will be responsible for leading and managing the company’s regulatory and quality initiatives across all product lines. This role will play a crucial part in ensuring compliance with both EU and US regulatory requirements, overseeing product registrations, and developing and implementing robust quality management systems. The ideal candidate will have a deep understanding of the regulatory landscape in the MedTech industry and experience in successfully navigating complex regulatory processes.
Key Responsibilities:
- Lead the regulatory strategy and manage submissions for product registrations in the EU and US markets.
- Ensure compliance with all relevant regulatory standards and guidelines, including CE marking, FDA approvals, and ISO certifications.
- Develop and maintain the company’s quality management system (QMS) to meet international standards.
- Collaborate closely with cross-functional teams, including R&D, clinical, and manufacturing, to ensure that products meet regulatory and quality requirements.
- Serve as the primary point of contact with regulatory bodies and notified bodies.
- Monitor and interpret regulatory changes and trends, ensuring the company remains compliant and competitive.
- Manage audits and inspections by regulatory authorities and customers.
- Provide leadership and mentorship to the regulatory and quality teams.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs).
- Extensive experience in regulatory affairs and quality management within the MedTech industry.
- Proven track record of successful regulatory submissions in both the EU and US.
- In-depth knowledge of EU MDR, FDA regulations, and ISO standards.
- Strong leadership skills with the ability to manage and develop a team.
- Excellent communication and interpersonal skills, with the ability to work collaboratively across departments.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work with cutting-edge technology in a rapidly growing company.
- Collaborative and innovative work environment.
- Potential for professional growth and development.
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