Job Description

Job Purpose (Role Definition):


The purpose of this role is to provide administrative support to the RA team, supply regulatory input and data and assist in compliance with standards and medical device regulations worldwide.



Main Duties and Responsibilities:

Assist in the preparation of documentation for the filing of regulatory submission to US FDA. Assist in the preparation of submission packages for European Agencies and other International Authorities within required timelines. Assist in maintaining regulatory information systems such as technical documentation and routine reports. Work within the RA team to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures. Assist in the compliance to global regulatory requirements and company policies. Assist with regulatory agencies and support with follow-up to inspections and audits (FDA, Notified Bodies etc.). Support the sales team and distributor network by providing administrative assistance to registration activities around the world.

Management Responsibilities:


None


Experience and Qualifications Required:


Mandatory:

Previous experience in a Regulatory Affairs role in a Medical Device organisation. Direct interaction with Regulatory authorities. Familiar with Quality System concepts, practices and procedures (for example, ISO 13485, MDSAP, CFR820). Familiar with Medical Device Directive and Medical Device Regulation. Experience working across export markets and dealing with international distributors.

Desirable:

Continuous improvement mindset. Strong user of MS Word and Excel. Previous experience in Project Management.

Key Skills and Competencies:

Enthusiastic to learn new skills. Able to work as part of a team and across multi-disciplinary teams on projects and represent the department when required. Good written and oral communication skills in English. * Time management - able to manage multiple projects and multiple deadlines.