Coordinate, review and maintain efforts associated with the preparation of regulatory documents for submissions such as CE, FDA, etc.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Work and communicate closely with company members to assist in obtaining regulatory approvals for the companys products.
Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures.
Review product promotional materials, Social media and labeling for compliance with applicable regulations and policies.
Write or update standard operating procedures, work instructions, or policies that support regulatory activity.
Participate in product development, as required, to ensure the product is in compliance with regulatory requirements
Support cross company processes as CAPA, NCRs, ECOs and custome
Requirements: o A Bachelors degree in a relevant field
o 3-5 years experience in regulatory Affairs, at a Medical Device Company
o Good Communication skills both verbally and in writing
o Good analytical skills
o High ability to work independently
o Self-motivated and proactive
o Fluent in English with excellent writing skills
o Excellent computer skills, including a working knowledge of Microsoft Office applications.
This position is open to all candidates.