Contract Opportunity - Medical Device Auditors
requirements such as MDSAP, MDD, MDR and EU. Decide upon evidence gained during audits whether or not registration...
requirements such as MDSAP, MDD, MDR and EU. Decide upon evidence gained during audits whether or not registration...
such as FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP. Essential Skills Proficiency in quality assurance and document...
. Working knowledge of EU MDR, MDSAP, and global regulatory requirements. Knowledge of ISO standards and risk management...
. Preferred experience preparing technical reports for regulatory submissions, such as EU MDR or equivalent...
), customer, and the EU throughout the project. Participate in lab testing, working closely with the delivery manager...
preferred. Experience preparing technical reports for regulatory submissions, such as EU MDR or equivalent preferred. NO C2C...
, Mexico, the EU, or Australia...
submissions, such as EU MDR or equivalent....
& Combination Products, including infusion pumps, on-body injectors, and pre-filled syringes. Understanding of FDA & EU Regulations..., or on-body injectors preferred. Knowledge of regulatory and standards such as ISO, 21 CFR Part 4, 21 CFR Part 820, EU MDD (93/42...
international travel. You will have the opportunity to work on studies in both the US and EU, and transition to overseeing LATAM...