Quality and Regulatory Affairs (QA/RA) Consultant
Op locatie, Remote- Lummen, Vlaams Gewest, België
Excellence Squad
Functieomschrijving
About Us:
Excellence Squad is a premier consultancy committed to advancing healthcare through comprehensive consulting services tailored to the diverse needs of the life sciences sector. Our mission is to empower and help companies across pharmaceuticals, biotechnology, and medical devices with expert guidance in regulatory affairs, quality assurance, and clinical solutions. We strive to ensure compliance, innovation, and patient safety throughout the product lifecycle. Our vision is to be the benchmark consulting firm renowned for our commitment to excellence and dedication to inspiring collaboration and growth within the industry.
Role Overview:
As a Consultant in Quality and Regulatory Affairs (QA/RA), you will play a vital role in guiding our clients through the complex regulatory landscape of the healthcare industry. You will lead projects, work on applications, inspections, regulations, clinical evaluation, standards, and contribute to development projects. Your responsibilities will encompass various aspects of quality management, regulatory compliance, and project management within the healthcare sector.
Key Responsibilities:
- Support clients in both the private and public sectors, ensuring adherence to regulatory standards and guidelines.
- Provide expertise in quality management systems, risk management, process validation, and audits at client sites or third-party audits.
- Assist in the development and implementation of regulatory strategies tailored to the specific needs of clients in the medical device and healthcare industry.
- Collaborate with cross-functional teams to ensure compliance with ISO standards, FDA regulations, and other international requirements.
- Guide clients through the regulatory approval process, including CE marking, technical documentation, and international registration applications.
- Conduct gap analyses, quality/regulatory training, and ongoing compliance support to facilitate successful product development and market access.
- Stay abreast of industry trends, regulatory updates, and best practices to provide strategic guidance and innovative solutions to clients.
Vereisten
Qualifications and Skills:
- Minimum of 2 years of experience in quality management and/or regulatory affairs within the medical device or healthcare sector.
- Bachelor's or Master's degree in engineering, biology, chemistry, pharmaceuticals, or an equivalent scientific qualification, or relevant work experience.
- Proficiency in English, as well as Dutch and/or French both spoken and written.
- Strong understanding of regulatory requirements, including MDD/MDR, IVDD/IVDR, ISO 13485, ISO 14971, and other relevant standards.
- Experience in conducting audits, managing quality management systems, and facilitating regulatory submissions.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently, yet thrive in a collaborative team environment.
- Passion for healthcare, technology, and innovation.
Why Excellence Squad:
- Impactful Work: Contribute to the development of products that improve or save lives.
- Competitive Compensation: Receive a competitive salary package with benefits.
- Growth Opportunities: Work in a valorizing environment with a focus on personal and professional development.
- Flexibility: Enjoy flexible working arrangements and remote work options depending on client needs.
- Expert Team: Join a dynamic team of industry experts passionate about making a difference in global healthcare.
If you believe you have the skills and experience to excel in this role, we invite you to submit your application today.
At Excellence Squad, we are committed to building a diverse and inclusive workplace. We welcome applications from all qualified individuals regardless of race, ethnicity, gender, sexual orientation, religion, or disability status. We do not accept inquiries from recruitment, staffing, or advertising companies.
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