Regulatory Affairs Administrator

The purpose of this role is to provide and maintain regulatory support, supply regulatory input and data and support compliance with standards, medical device regulations worldwide, and appropriate pharmaceutical regulations to Rayner’s product range and target markets.

Your key responsibilities will be:

• Provide support for RA activity - this includes (but is not limited to):

• Maintaining departmental training records

• Supporting the Pharmaceutical QARA Manager in QMS maintenance activity

• Provide administrative support to the RA team in the following areas:

• Management Review

• Internal and External Audits

• Support equipment, system and process development in-house and with suppliers

• Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. FDA, Notified Bodies etc)

• All such other tasks as may be reasonably required to support the activities of the Regulatory Affairs department and the Company

Competencies:

• Teamwork: Contributes fully to the team effort and plays an integral part in the smooth running of teams without necessarily taking the lead
• Adaptability: Adjusts to changing environments whilst maintaining effectiveness
• Flexibility: Modifies his or her approach to achieve a goal. Is open to change and new information; rapidly adapts to new information, changing conditions, or unexpected obstacles
• External Awareness: Understands and keeps up to date on local, national, and international policies and trends that affect the organization and shape stakeholders' views; is aware of the organisation's impact on the external environment
• Compliance: Conforms to company policies and procedures

Qualifications:

Essential

Either:

1. Qualification in a science, clinical or engineering subject, or

2. 1-2 years experience in an Operations, Quality or Regulatory role in a medical devices or pharmaceutical company

3. Familiar with Quality System concepts, practices and procedures (e.g. ISO 13485, CFR820)

4. Familiar with databases and business management systems (ERP)

Desirable

• Familiar with the Medical Device Directive/Medical Device Regulation
• Direct interaction with regulatory authorities (Notified Bodies, Competent Authorities, Government Agencies etc)
• Experience working across export markets and dealing with international distributors