3428260 Regulatory Affairs Intern Healthcare Quality GE Healthcare Peru
The position may be involved in Premarket duties. He/she improves subject matter expertise and works with a team of RA professionals to ensure GEHC establishes best practices in premarket submission, and ensures accurate & optimal submission of medical devices clearance files.
Meet the requirements for regulatory submission processes:
- Create regulatory compliance / project plan to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions.
- Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
- Establish plans and deliverables for timely submission for renewal of licenses
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.
Progressive regulatory affairs experience in medical device industry and with medical product regulatory agency, including knowledge & experience applying on device laws & regulations for product registration processes. Ability to prioritize, plan & evaluate deliverables to established strategic goals.
- Careers: Pharmacist, Biomedical Engineer, Industrial Engineer or Pharmacist Pre professional trainee with excellent verbal and written communication and presentation skills.
- Ability to communicate business issues in English in an easy to understand manner.
- Ability to work well independently & in a team setting.
- Strong problem solving and negotiation skills.
- At least 24 credit hours of coursework toward a bachelors/technical (or equivalent) degree in the function you are interning or a recent graduate from a Bachelors/technical program in the function you are interning.
- In countries where applicable, a GPA of at least 3.03. Ability to exercise independent judgment consistent with department guidelines.
- Previous experience using independent thought processes to plan ahead, process information, maintain workflow and anticipate future needs of the team.
- Strong organizational skills with high attention to detail.
- Self-Starter, proactive, able to work independently with minimal direction.
- Ability to quickly identify and prioritize issues, create solutions and meet deadlines.
- Team player with strong interpersonal skills, capable of working within a globally diverse team across different time zones.
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com