To undertake EUMDR gap analysis for Stanmore implants commercial division. Delivery of EUMDR requirements to ensure the Stanmore implants commercial division is compliant with new regulations on time and in full. Coordinate and be the focal employee for the business needs of our newly established Dutch branch in The Netherlands.
Delivery of EUMDR requirements for the Stanmore commercial business
Work under guidance of Commercial Director, Product Manager and EUMDR Project Manager to deliver the necessary documentation on time and in full on behalf of the commercial business.
Be the Coordinator for our newly established Dutch Stanmore branch based in Amsterdam and handle customer enquiries from mainland Europe
Track orders for custom implants in mainland Europe.
Coordinate marketing activities and promotions in mainland Europe together with the European Product Manager.
Ensure accurate financial reporting for the Dutch branch working closely with financial colleagues to ensure compliance with all compliance and regulations
Report out on weekly progress
Occasional travel to Stanmore, London to stay aligned on all projects
Ensure all documentation is compliant and audit ready
Work with sub-contractors to deliver outputs (translators and design agencies).
Build and maintain relationships with other Enabling Functions such as Design Office, Finance, RAQA, Clinical and Commercial.
Update standard operating procedures to be in line with new requirements following the gap assessment.
Route documentation updates through the site’s change control QMS procedures.
Key requirements for this position are :-
2-5 years working within a regulatory environment.
Knowledge of MDD and EUMDR regulations preferred
Experience of the MedTech industry
Must be resident in The Netherlands
Demonstrated proficiency in the writing of technical documents/dossiers
Proven ability to coordinate others in the delivery of results
Will be able to demonstrate an ability to work in a business where quality is at the forefront of everything we do
Previous work experience within a global business
Language skills an advantage but not essential. Must be fluent in both verbal and written English.
Demonstrated networking and influencing skills with the ability to drive results through a global matrix structure is required.
Proven ability to communicate and present to all levels of the organization, inclusive of Senior Leadership.
Demonstrated ability to work to deadlines
Demonstrated ability to work within a team across different departments: Commercial, R and D, Finance, Quality, Regulatory and Operations.
Demonstrated proficiency in Microsoft Office Suite, including Excel, Word and PowerPoint. Knowledge of Syspro an advantage.