Regulatory Affairs Specialist

Forma-TK Systems is a global developer and manufacturer of technologically driven devices for the non-invasive medical aesthetic market. Established in 2008, Formatk has demonstrated a rapid growth and now operates in more than 40 countries worldwide.

Role Description:

The Regulatory Affairs Specialist will be responsible for ensuring regulatory activities are effectively executed to meet the business objectives. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder. Your work will include close contact with QA and Engineering teams and Management.

Responsibilities

• Preparation of product dossiers and submission for registration.
• Review of documents, and preparations of additional documentation for international product registration.
• Coordination with international entities and various internal company interfaces.
• Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
• Proven experience writing system description, operation, maintenance and hardware manuals 

Job Requirements:

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, Chemical Engineering, Quality Assurance, or related fields.
• Excellent proficiency in English (reading, email correspondence, and conversational fluency) – mandatory.
• Experience in a medical aesthetic company or similar industry in Regulatory Affairs – significant advantage.
• A minimum of 5 years of Regulatory Affairs experience
• RAPS RAC (Medical Device) - Advantage