Regulatory Affairs Specialist
Be part of a growing multinational company in Medical Devices sector
Contribute to the company´s consolidation in Colombia and the region
Acerca de nuestro cliente
Well-known multinational company of medical devices sector.
Descripción de la oferta
The position of Regulatory Affairs Specialist main responsibilities will be:
- Assist with determination of global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required;
- Interacts with various levels of management, external agencies, and companies;
- Assists with developing, maintaining and analyzing department systems and provides training when needed;
- Remains current on developing regulations and revises systems as necessary;
- Participates in and assists with facility inspections, other governmental inspections as directed;
- Performs other related duties and tasks, as required;
- Prepares documentation/submissions to defined criteria in liaison with distributors, Regional Offices, International Government Agencies / Ministries of Health with a particular focus on Colombia and other North Latin American countries;
- Develops internal documentation as requested.
Perfil buscado (h/m)
- Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience;
- Demonstrated knowledge of global regulatory requirements with particular emphasis on Colombia and other North Latin American regulatory frameworks;
- Self-motivated, self-directing, strong attention to detail and excellent time management skills;
- Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others;
- Experience in preparing technical documentation, editing, proofreading preferred;
- English language skills strongly preferred;
- Supervisory experience is desirable;
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
Be part of a growing company in LATAM with a great career path and contribute to its positioning through coordinating, preparing, and maintaining regulatory submissions and documents.