Regulatory Consultant, Medical Device (Home-Based, Germany) IQVIA MedTech
- Experience Level
- Experienced (non-manager)
IQVIA MedTech Solutions, including Genae which is a fully owned business unit of IQVIA, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.
IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.
In this highly specialized and dynamic role you will provide medical devices regulatory affairs consulting services to meet client expectations through the development, implementation, and delivery of regulatory consulting programs.
- Facilitate client engagements and manage project deliverables.
- Partner and liaise with MedTech Clinical Solutions, Technical Writing and other IQVIA business leads to perform projects in accordance with client expectations and guidance from the superiors.
- Responsible and accountable for results of assigned engagements
- Seek and gain proficiency of skills and knowledge,
- Meet competency proficiency for grade 140.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Enthusiastic and eager to learn and expertise in regulatory affairs of medical devices
- Strong interpersonal and organizational skills, responsible and aspiring.
- Excellent verbal and written communication skills.
- Self-learner and team player.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- 3 years’ related experience in the medical device industry.
- Experience in certified QMS environment per ISO13485 / FDA-QSR.
- Bachelor's degree in life science-related discipline or engineering.