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- Aufgaben: Lead global quality and regulatory strategies in the medical device industry.
- Arbeitgeber: Join a leading medical device company focused on innovation and excellence.
- Mitarbeitervorteile: Enjoy flexible hours, remote work options, and a competitive salary package.
- Warum dieser Job: Make a real impact in healthcare while fostering a culture of continuous improvement.
- Gewünschte Qualifikationen: Requires 8+ years in quality and regulatory roles, with strong leadership skills.
- Andere Informationen: Willingness to travel internationally is necessary.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
This Exclusive mandate seeks a highly experienced and motivated Global Head of Quality and Regulatory with direct leadership expertise and hands-on mentality to join a dynamic client in the medical device field. This leadership role is critical in ensuring our products meet the highest standards of quality and regulatory compliance across all markets.
Key Responsibilities:
- Leadership and Strategy : Develop and implement global quality and regulatory strategies to ensure compliance with international standards and regulations.
- Regulatory Compliance : Oversee the preparation and submission of regulatory filings, ensuring timely approvals for new products and maintaining compliance for existing products.
- Quality Management : Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
- Risk Management : Ensure robust risk management processes are in place, including risk assessments, CAPAs, and continuous improvement initiatives.
- Team Management : Lead and mentor a global team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement.
- Stakeholder Collaboration : Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory requirements are integrated into product development and lifecycle management.
- Audits and Inspections : Manage internal and external audits, including those conducted by regulatory bodies, and ensure timely resolution of any findings.
- Regulatory Intelligence : Stay abreast of global regulatory changes and trends, and proactively adjust strategies to maintain compliance and competitive advantage.
Qualifications:
- Education : Advanced degree in a relevant field such as biomedical engineering, regulatory affairs, or a related discipline.
- Experience : Minimum of 8 years of experience in quality and regulatory roles within the medical device industry, with at least 5 years in a senior leadership position.
- Knowledge : In-depth knowledge of global regulatory requirements, including FDA, EMA, and other international regulatory bodies.
- Skills : Strong leadership and team management skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced, dynamic environment.
- Certifications : Relevant certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are highly desirable.
- Travel : Willingness to travel internationally as required.
What We Offer:
- Innovative Environment : Be part of a leading medical device company that is at the forefront of innovation.
- Professional Growth : Opportunities for continuous learning and professional development.
- Competitive Compensation : Attractive salary and benefits package.
- Work-Life Balance : Flexible working hours and the possibility of remote work arrangements.
- Supportive Culture : A collaborative and inclusive work environment that values diversity and teamwork.
- Company Car
Seniority level
Not Applicable
Employment type
Full-time
Job function
Quality Assurance and Manufacturing
Industries
Medical Equipment Manufacturing
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Global Head of QA/RA Arbeitgeber: EPM Scientific
Kontaktperson:
EPM Scientific HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Global Head of QA/RA
✨Tip Number 1
Network with professionals in the medical device industry, especially those who have experience in quality and regulatory roles. Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Stay updated on global regulatory changes by following relevant organizations and publications. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining compliance and staying ahead in the industry.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led teams and implemented quality management systems in previous roles. Highlight your hands-on approach and ability to foster a culture of excellence within your team.
✨Tip Number 4
Research the company’s current products and their regulatory status. Understanding their portfolio will allow you to tailor your discussions during the interview and show how your expertise can directly benefit their operations.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Global Head of QA/RA
Tipps für deine Bewerbung 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Global Head of QA/RA position. Tailor your application to highlight your relevant experience in quality and regulatory roles within the medical device industry.
Highlight Leadership Experience: Emphasize your leadership skills and experience in managing teams. Provide specific examples of how you've developed and implemented quality and regulatory strategies in previous roles, particularly in a fast-paced environment.
Showcase Regulatory Knowledge: Demonstrate your in-depth knowledge of global regulatory requirements, including FDA and EMA standards. Mention any relevant certifications you hold, such as RAC or CQE, to strengthen your application.
Craft a Compelling Cover Letter: Write a tailored cover letter that connects your background and skills to the job description. Discuss your passion for quality assurance and regulatory compliance in the medical device field, and how you can contribute to the company's success.
Wie du dich auf ein Vorstellungsgespräch bei EPM Scientific vorbereitest
✨Showcase Your Leadership Experience
As a Global Head of QA/RA, your leadership skills are crucial. Be prepared to discuss specific examples of how you've successfully led teams in the past, particularly in the medical device industry. Highlight your hands-on approach and how it has positively impacted quality and regulatory compliance.
✨Demonstrate Regulatory Knowledge
Make sure to brush up on global regulatory requirements, especially those related to FDA and EMA. During the interview, be ready to discuss how you have navigated complex regulatory landscapes and ensured compliance in previous roles.
✨Discuss Quality Management Systems
Familiarize yourself with ISO 13485 and other relevant standards. Be prepared to explain how you have developed, implemented, and maintained Quality Management Systems in your past positions, and how these systems contributed to product quality and safety.
✨Emphasize Collaboration Skills
This role requires collaboration with various departments. Share examples of how you've worked cross-functionally with R&D, manufacturing, and marketing teams to integrate quality and regulatory requirements into product development. Highlight your communication skills and ability to foster teamwork.
