Post Market Surveillance Associate
We are partnering with a global Medical Device company to appoint a Post Market Surveillance Associate. This position will focus on post market surveillance, vigilance, complaints handling and data analysis and reporting.
The ideal candidate will be a recent graduate from Biology/Scientific disciplines or those that have an initial 1 to 2 years' similar experience in a Medical devices/ Pharmaceuticals .
This is the opportunity to join the company at an exciting and key time as they reform best practices and focus on continuous improvement within the Quality & regulatory department. This environment will provide an excellent platform for career development; providing great learning opportunities within a fast-paced company.
The role may require up to 15% travel to support visits to other offices, customer sites, certification bodies and regulatory authorities.
Post Market Responsibilities:
- This role will also be responsible for supporting Post Market Surveillance Manager in the identification and prioritisation of issues that have or may result in customer dissatisfaction and product safety issues.
- Interpret and apply regulations to existing products to ensure compliance with vigilance and reporting requirements.
- Keep up-to-date with the company's complete product range and attend relevant training.
- Ensure that all customer complaints are logged in the relevant company systems in a timely manner in-line with company procedures.
- Ensuring that customer reported complaints are investigated adequately, root cause findings and corrective action results are communicated to appropriate internal staff and external customers in a timely manner.
- Monitor, collate, and publish data for action or escalation in coordination with local stakeholders and other regional / group post market surveillance teams.
- Support assigned complaint handling, field action and reporting teams initiatives.
- Work on vigilance/reporting documents, or create new templates in compliance with group policies and directives.
- Provide regular reporting to Post Market Surveillance Team on the status of complaint investigations, vigilance reporting and field action closures.
- Good reporting and data analysis/ trending skills.
- Strong computer literacy with knowledge of Microsoft Excel, Word, Powerpoint.
- Knowledge of QMS/complaint management computer based systems would be advantageous.
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.