The major duties of this job will involve much structure, will require attention to detail, and must be done correctly. At the same time job tasks will vary rather than be repetitive and will require a faster-than-average pace in order to complete work requirements. The position may be integral to teamwork in the organization, and in satisfying both internal and external customers. This job has a hands-on focus, where productivity is gained through individual accomplishments.
- Develop a thorough understanding of the clients/client’s projects that are assigned.
- When on client projects, act as the face of Trinzo always presentable,
approachable, and professional.
- Coordinate multiple projects at one time and provide regulatory support as required.
- Assist in the implementation of global regulatory strategies for client’s medical
devices in collaboration with other regulatory affairs or clinical personal (as
applicable), on different classes of devices.
- Work with the Client’s EU MDR implementation team to ensure processes and
procedures are put in place.
- Maintain close contact and links with relevant client manufacturing sites and ensure contracts are in place.
- Maintains registration information (license numbers, expiration dates, regulatory
logs for annual reports, filing / printing of regulatory submissions, correspondence
- Working with other functional units / departments in assessing changes to medical
devices, determination of regulatory impact and communication to regulatory
- Assistance in procedure updates where required.
- Provides support to currently marketed products as necessary including input on
change requests, PMS, Regulatory Reporting etc.
- Maintain and organise appropriate regulatory records to demonstrate compliance
with applicable regulations.
- Assist in post market responsibilities as required.
- Liaise effectively with regulators on all issues with regard to regulatory reporting and
field safety corrective action.
- Ensuring that confirmed reportable events are escalated to the appropriate
personnel in a timely manner.
- Generate various reports, including but not limited to, Regulatory requests,
Marketing requests, Engineering requests.
- Assist in coordination of Recall administration activities between manufacturer and
- Performs additional duties as assigned.
- Fast paced environment.
- Very detail orientated, tasks must be completed quickly and correctly.
- Decisions made only within authorized boundaries, with assistance from management.
- Requires collaborative teamwork, within a supportive environment.
- Excellent communication and inter-personal skills.
- Proven problem-solving skills.
- Good computer skills.
- Proven organisational skills.
- High self-motivation.
- Willingness to travel on company business when required.
- Third level Qualification in Science/Engineering.
- 10 years exp in Regulatory.
- Good knowledge of MDR.
- Expert knowledge of medical device quality standards/practises.
- Ability to work remotely.
Are you an experienced, proactive problem-solver?