Head Of Quality, Regulatory Affairs

SASMAR is searching for a dedicated and experienced professional to fill the role of Head Of Quality and Regulatory Affairs. Our company, headquartered in Ta' Xbiex Malta, and with a presence across key global markets including Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, specializes in developing innovative personal care and fertility products, exemplified by our well-known brand, Conceive Plus. We take pride in our ability to distribute our products in over 70 countries through a variety of channels, including supermarkets, clinics, hospitals, pharmacies, and drugstores.

In this pivotal role, you will be responsible for leading our Quality Assurance and Regulatory Affairs teams, ensuring that SASMAR maintains the highest standards of product safety and compliance with all relevant regulations globally. You will spearhead initiatives to enhance our quality management systems while facilitating a culture of quality throughout the organization.

We are committed to fostering an inclusive and diverse workplace that provides equal opportunities for all employees, and we are looking for someone who shares our values and vision for excellence.

• Develop and implement comprehensive quality assurance strategies and regulatory compliance frameworks.
• Oversee product safety assessments and risk management activities to support regulatory submissions.
• Collaborate with cross-functional teams to continuously improve processes and implement industry best practices.
• Ensure compliance with international regulatory standards, submitting thorough documentation as required.
• Stay updated on regulatory developments and assess their implications for SASMAR's products and operations.
• Maintain strong relationships with regulatory agencies, conducting audits and inspections as needed.
• Review and endorse quality-related documentation, including SOPs, validation protocols, and technical files.
• Provide expert guidance to support new product development and enhancements, ensuring alignment with regulatory requirements.

Requirements

• A Bachelor's degree in a scientific discipline such as Pharmacy, Chemistry, or Biology; an advanced degree is an asset.
• Significant experience in Quality and Regulatory Affairs within the pharmaceutical or medical device sectors.
• Comprehensive understanding of global regulatory frameworks, including but not limited to FDA and EMA guidelines.
• Demonstrated leadership skills with experience managing diverse teams.
• Thorough knowledge of quality management systems, particularly ISO 13485 and other relevant certifications.
• Strong background in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Outstanding analytical and problem-solving capabilities.
• Excellent written and verbal communication skills.
• Adaptability to a dynamic and fast-paced work environment.
• Experience in conducting regulatory audits and inspections is highly beneficial.
• Relevant certifications in quality management and regulatory affairs are preferred.
• Candidates MUST have permission to work in Malta, no permits offered for this role.

Benefits

• Competitive salary
• English language and multi-cultural work environment
• Private Health Insurance (medical, dental, hospitalisation)
• Career advancement opportunities in stable company
• Modern offices, convenient to public transport.

This position is based at our new villa offices in Ta' Xbiex, Malta.