General Electric Regulatory Affairs Specialist Middle-East & Africa in Athens, Greece
Job Description Summary
As Regulatory Affairs Specialist you will provide regulatory input to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own work and the work of others on the team. You will be focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Roles and Responsibilities
Support for all marketing authorisation-relevant activities of GE Healthcare's medicinal products,
Providing assistance with the submission of marketing authorisation and renewal applications, notifications of changes,
Communication and coordination with stakeholders to ensure the necessary measures for maintaining regulatory compliance of the existing drug approvals (Life Cycle Management),
Preparation, update and review SmPC for HCPs and PILs in the context of drug approval in compliance with the currently valid legal requirements,
Maintain the quality management systems through the development and continuous revision of Standard operating procedures to ensure safety and the well-being of patients,
Bachelor Degree in a relevant field such as: Regulatory Science, Biomedical Engineering, Biology, Pharmacy, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science
experience in regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities
strong analytical skills
work with less supervision on projects and activities
able to prioritize, plan & evaluate deliverables
excellent verbal and written communication and presentation skills with the ability to communicate in English
Ability to work in a team and working independently,
Decision-making competence, sense of responsibility, reliability and flexibility,
Ability to work across cultures,
Ability to manage regulatory processes to ensure approvals and maintenance of products,
Fluency in French will be an asset.
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Relocation Assistance Provided: No