Expert Medical Systems Products
On-site · Bengaluru, Karnataka, India
Job Summary
Authorship of Clinical Evaluation Reports (CERs) and related documents in alignment with leadership to demonstrate efficacy and safety for product registrations and to evaluate clinical applications. Provide support in medico-regulatory topics, risk management documentation, and cross-functional teams for medical-regulatory activities. Contribute to assessments of product development issues through analysis of clinical data and defining medical evidence needs in collaboration with the therapy field director. Plan and support medico-scientific activities and generation of clinical evidence (studies) in close alignment with the director and Clinical Research. Requires a university degree in a relevant science, at least 5 years of experience in healthcare or medical technology sectors, and strong knowledge of medical device regulations (MDR).
Required Qualifications
- University degree in Medicine, Pharmacy, natural science, medical engineering or related science
- At least 5 years of work experience, preferably in health care or pharmaceutic or medical technology companies or research institutions
- Experience in medical device regulations and compliance (Medical Device Regulation, MDR)
- Competence in direct compilation of medical and scientific documents and coordination of contributions from multiple departments
- Experience in conducting systemic and process-oriented research in medical and scientific databases
- Familiarity with dialysis/nephrology products/topics
- Analytical, self-motivated, structured working method
- Strong communication and teamwork skills
- Inter-cultural competence
- Willingness to collaborate with cross-functional teams
- Ability to plan and support medico-scientific activities related to generation of clinical evidence
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.