Regulatory Affairs &
Quality Assurance -Medical Devices
(Technical Director)
Lima, Perú
About the Company
Global Regulatory Affairs is looking for an In-House Regulatory Affairs & Quality Assurance Coordinator (Technical Director) to be placed in one of our most important client, A multinational Swiss medical device company. This is a great career opportunity for an experienced professional.
About the Role
1.- Regulatory Affairs Responsibilities
Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to DIGEMID
Ensures maintenance of assigned, authorized products through timely submission of renewal applications, and post approval variations.
Track process and manages answers to queries from the Agency
Keeping track of the open submissions and projects, analysing & closing the gaps as required by DIGEMID
Responding to customer RA requests by providing document and information and providing support for tender RA documentation
Perform other administrative related duties as assigned.
Coordination of translations
2--Quality management responsibilities
Be the technical director according to Peruvian regulation
Release products to market : Perform collaborative review of incoming products for release to Peruvian market
Returns verification / inspection according to local SOP
Quality complaint
Perform periodic random inspection to Logistics Operator / stakeholder / supplier according to client policy / SOPs
Ensure compliance to codes, standards, regulations and QMS requirements, including creation/revision of appropriate SOPs
Manage Deviations / CAPA
Requirements
Licensed pharmacist with +3 years of experience with local & international training in Medical device regulatory environment & Quality system
Good interpersonal skills including ability to interact with internal staff and external customers with a high degree of diplomacy.
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within internal and external commitment dates.
Effective problem-solving skills
Strong communication / presentation and organization skills.
Upper intermediate English level
Expertise in Microsoft Office applications and charting programs
Apply
Contact
Global
Regulatory
Affairs
SkyTower Business Center
Av. Javier Prado Oeste 757. Off. 1004
Zipcode: 15076
Lima-Perú
Email: info@gra.com.pe
Tel: +51 902 733 083