Product Lead (IVD)

  • Category
    Health & Medicine - Pharmaceutical
  • Location
    Dundee, Dundee City
  • External Reference
  • OrganizationType

Product Lead - In Vitro Diagnostics

Spring Technology are currently recruiting for an experienced Product Lead (IVD background) to undertake a 12 month fixed term assignment for a leading Medical Device/Healthcare Company.

Duties and responsibilities, along with experience and background expectations detailed below:

Working in conjunction with a small Team of Product Support Investigators

* Coordinate Complaint investigations, ensuring timely resolution to issues.

* Assess reportability status of end user complaints

* Coordinating Supplier Corrective Action (SCARs)

* Manage Post Market Surveillance Activities including product stability and participation within proficiency schemes

* Maintain and report to management on Complaint metrics and trends.

* Supporting internal and external audits as needed.

* Support the coordination of any potential quality hold or field corrective action.

* Oversee 'in-house' Design Validation, product dating studies and bespoke studies in support of Scientific Marketing activities. Provide line management to the Product Support Team

You will posses...

* Bachelor's degree in a scientific discipline (or equivalent experience in a quality related field) is required.

* Ideally you will have experience of complaint handling

* Experience in adverse event reporting processes

* IVD background

* Knowledge in the Medical Device Single Audit Program (MDSAP) and associated regulations/standards including IVDD

* Ability to influence without direct authority

* Strong negotiation skills

* Demonstrable line management experience.

How you will work...

* Must have excellent written and verbal communication skills. Must be able to write in a manner that effectively conveys complex issues to the reader.

* Good analytical/ critical thinking skills.

* Must be able to manage multiple priorities at the same time and meet timelines.

* Strong communication, facilitation, planning, problem-solving and organisational skills.

* Ability to interpret regulatory request with respect to written requirements.

* Experience facilitating group meetings, managing conflict, recording and assigning action items. Spring Technology acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.

By applying for this role your details will be submitted to Spring. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser:

To speak to a recruitment expert please contact Simon Dawson