RAQA Executive

Barrington James Limited; Malaysia; On-site; MYR 100,000 - 150,000; Full time

Job summary

Ein innovatives Unternehmen in der Medizintechnik sucht einen erfahrenen RAQA Executive, um die Qualitätssicherung und regulatorischen Angelegenheiten für kardiovaskuläre Geräte in Indonesien zu leiten. In dieser Schlüsselrolle stellen Sie sicher, dass Produkte höchsten Qualitätsstandards entsprechen und alle lokalen Vorschriften eingehalten werden. Sie werden eng mit funktionsübergreifenden Teams zusammenarbeiten und sich über die neuesten Entwicklungen in der Branche informieren. Wenn Sie leidenschaftlich daran interessiert sind, das Gesundheitswesen zu verbessern und über die erforderlichen Fähigkeiten verfügen, freuen wir uns auf Ihre Bewerbung und darauf, gemeinsam einen positiven Einfluss zu erzielen.

Qualifications

• Erfahrung in Qualitätssicherung und regulatorischen Angelegenheiten in der Medizintechnik.
• Kenntnisse über kardiovaskuläre Geräte und lokale regulatorische Anforderungen.

Responsibilities

• Überwachung der Qualitätssicherung und regulatorischen Angelegenheiten für medizinische Geräte.
• Verwaltung des regulatorischen Einreichungsprozesses und Zusammenarbeit mit Teams.

Skills

Qualitätsmanagement

Regulatory Affairs

Kommunikationsfähigkeiten

Problemlösungsfähigkeiten

Interpersonelle Fähigkeiten

Job description

Our client is a large Medical Device company with a range of commercialized products. They are committed to providing high-quality medical devices that improve the lives of patients around the world. We are dedicated to innovation, excellence, and making a positive impact in the healthcare industry. Our inclusive and diverse company culture allows us to leverage the unique talents of our employees to drive our success.

The Role

We are seeking a talented and experienced RAQA Executive to join our team and oversee the quality assurance and regulatory affairs for our medical devices in the Indonesia market. As the RAQA Executive, you will play a crucial role in ensuring that our products meet the highest standards of quality and compliance with local regulations. You will be responsible for managing the regulatory submission process, collaborating with cross-functional teams, and staying abreast of the latest developments in the industry. This role will specifically focus on cardio vascular devices such as stents and one-time use devices.

About You

• Proven experience in quality assurance and regulatory affairs within the medical device industry
• In-depth knowledge of cardio vascular devices, stents, and one-time use devices
• Strong understanding of the regulatory requirements in the Indonesia market
• Excellent communication and interpersonal skills
• Ability to work effectively in a cross-functional and multicultural environment
• Commitment to diversity, equality, and inclusion in the workplace
• Strong problem-solving skills and attention to detail

If you are passionate about making a difference in healthcare and possess the skills and experience required for this role, we would love to hear from you. Join our team at [Company Name] and contribute to our mission of delivering life-changing medical devices to patients in Indonesia and beyond.