An exciting, high-growth biopharmaceutical company is currently recruiting for a Medical Device Technical Manager to join their multinational workplace with employees from all over the world, in beautiful Reykjavik, Iceland. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing.
Full relocation package is available for the successful candidate including cash allowance and free accommodation for the first 4 weeks.
Responsibilities
- Leads their development project and documentation thereof from start to finish including human factors (usability) testing, design verification testing, and product finalization.
- Develop and maintain technical subject matter expertise in the function and testing of the devices that are part of the company's combination drug product.
- Develop and maintain a working knowledge of regulations surrounding combination drug products.
- Draft source documents for dossier filing, contribute to risk assessments and SOPs
- Works with QA to maintain Design History File.
- Co-ordinates and maintains samples for shipment with supply chain.
- Day to day coordination of technical projects with vendors and reviews all technical documents
- Coordinates outsourced engineering and assembly activities.
Experience and Qualifications
- Must have a demonstrated ability to work across departments.
- Must have a demonstrated ability to manage projects (academic or industrial).
- Must be organized, take initiative, be prepared to challenge and have strong communication skills.
- Preferred. BSc. Equivalent minimally. Engineering, pharmaceutical sciences, biochemistry or related field.
- Human factor engineering experience a plus.
- Machinery experience a plus.
- Demonstrated record of managing a project (academic or otherwise) a must.
- Demonstrated experience with statistics.
To Apply
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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