|Date Posted||August 5, 2022|
What You will Do
Facilitating the design control process with integrated activities in risk management for combination products. Makes decisions that require choosing between multiple options to resolve complex problems; Works in ambiguous situations within own workgroup/team; works predominantly within established procedures while introducing some new knowledge and methodologies.
Support human factors team from formative usability assessments to final summative design validation studies for combination products.
Applies technical and functional knowledge to independently conducts research in the assigned area.
Assist with project planning regarding Risk Management activities. Conducts independent research; generates internal or external documents/reports and presentations related to own work and produces patentable ideas.
Develop relationships with other groups. Explains difficult or sensitive information; works to build consensus; Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain and defend work.
Participation in regulatory filings and working with external collaborators. Plays a critical role in the write-up of regulatory filings and answering regulatory questions.
Who You Are?
Are you a strong Risk Management leader with the ability to facilitate the interface between the pharmaceutical company and the medical device vendor base with good communication, collaboration, and team-building skills; with ability to connect with all levels of the organization?
Do you have experience of working with third-party vendors for Human Factor Studies and developing, or reviewing and approving the project design control documents and project Risk Management documents?
If so, then we would be interested in speaking with you!
Bachelor s Degree with a focus in Engineering.
8+ years experience in design control, Risk Management or related area like human factors.
Master s Degree or Phd with a focus in Engineering
Knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW.
Good understanding of new product introduction, design, and development of extruded, molded and/or assembled device products.
Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organization.
Thanks and Regards,
PH - (phone number removed).