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Quality and Regulatory Affairs (QA/RA) Consultant

Remote: 
Full Remote
Contract: 
Part time
Work from: 
Belgium

Offer summary

Key responsabilities:

  • Support clients to adhere to regulatory standards and guidelines
  • Provide expertise in quality management systems and audits
  • Assist in developing and implementing regulatory strategies
  • Collaborate for compliance with ISO and FDA regulations
  • Guide clients through regulatory approval processes and compliance
Flexorius - HR, mét hoofdletters logo
Flexorius - HR, mét hoofdletters Human Resources, Staffing & Recruiting Startup https://www.flexorius.hr/
11 - 50 Employees
About Flexorius - HR, mét hoofdletters
Bedrijven groeien als mensen floreren. Wij ondersteunen en adviseren je in de groei van je organisatie én je mensen. Samen met jou brengen we jouw HR-noden, doelen en dromen in kaart. We werken aan de hand van 3 pijlers: ondernemen, ondersteunen en ontwikkelen. Wat wil dit zeggen? - We zijn sterk in mensen én alle paperassen die daarbij komen kijken. - We hebben een kritische blik én denken strategisch met je mee. - We zorgen dat je mensen groeien in skills én als mens. Onze aanpak is steeds persoonlijk en afgestemd op wat jij nodig hebt en nog wilt bereiken. Van het uitstippelen van een strategisch HR- of opleidingsbeleid, het opzetten van aangepaste HR- processen & tools, het ondersteunen in HR-taken tot het individueel & collectief ontwikkelen van medewerkers en organisaties. HR, mét hoofdletters. Want we zijn er elke dag mee bezig. En we delen onze expertise met plezier.
See more Flexorius - HR, mét hoofdletters offers

Job description

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.

Required profile

Experience

Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Quality Management SystemsRisk ManagementRegulatory ComplianceProject ManagementRegistrationAuditingISO/IEC StandardsFDA RegulationsProcess ValidationTechnical DocumentationGap AnalysisRegulatory FrameworksCompliance Training

Other Skills

  • Collaboration
  • Communication
Are you interested?

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