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Careers and Partnerships. If you are a consultant looking to join a growing and collaborative team of experts, we would like to hear from you.

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.


We look forward to meeting you!

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