Guideline Medical is a trusted community of FDA regulatory and compliance consultants.
We are expanding our medical device consulting focus to also include Pharmaceutical and Bio-tech industry services.
Some preferred qualifications include:
Bachelors or Master’s degree and at least 5-7 years of hands on experience in the medical device or pharmaceutical regulatory and manufacturing industries.
Quality Assurance work can include: CE mark experience, development of technical files, design dossiers, risk management reports, and knowledge of IEC and ASTM testing, ISO-13485 and other ISO testing standards. Medical device or pharmaceutical manufacturing auditing experience, CAPA experience and SOP development knowledge.
FDA Regulatory experience can include: Device experience: 510k, De Novo, PMA, IDE, HDE submissions. FDA warning letters, 483s, consent decrees.
Drug and biologic experience: IND, ANDA, NDA, BLA.
