Sales Specialist, OEM
Continental Disc Corporation
Salary
💰 $104,000 - $193,000 per year
Job Level
Mid-LevelSenior
About the role
- Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams.
- Manage neurology, cardiology and core reagents product registrations in the United States, Europe and China and support worldwide registrations.
- Give regulatory guidance on strategic and tactical topics to stakeholders and cross-functional project teams.
- Prepare and submit premarket submissions to FDA or Notified Bodies, serving as the primary interface.
- Interact with regulatory agency personnel to expedite approval/clearance of pending registrations and answer questions.
- Support product care activities and update technical documentation of the product portfolio.
- Collaborate closely with colleagues in Germany, Switzerland, the US and global Regulatory Affairs teams, especially in China and Japan.
Requirements
- Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
- 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
- Technical understanding of medical devices or IVDs.
- In-depth knowledge of immunoassays is highly desirable.
- Knowledge in international laws and regulations for development, manufacturing and registration of IVDs especially in EU, US and China.
- Proven experience in managing overlapping projects and strong self-organization.
- Ability to work independently, reliably, and with exceptional flexibility; able to shift priorities and balance multiple commitments.
- Collaborative spirit and ability to work cross-functionally and internationally.
- Local to Indianapolis, Indiana, Mannheim or Penzberg Germany (or willing to relocate); remote work considered only under extraordinary circumstances.
