Senior Biocompatibility Specialist- Medical Devices (remote)

The company is multinational company and global leader in their market. They manufacture, market and distribute high quality and high-tech products worldwide. Their innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients. It's their promise to look beyond what's possible now and discover what's possible next. Their mission is to alleviate pain and improve the quality of life around the world; and to achieve this, they are investing significantly in new technology and processes to transform their ways of working and unlock greater growth potential in their business.

Candidates can be based anywhere in Ireland as they work fully remote (+ 10% travelling).

The Senior Biocompatibility Specialist is a.o. responsible for planning, organizing, and conducting biological safety risk assessments on medical devices in accordance with current regulations. Frequent communication with internal and external customers is expected. Both teamwork and individual contributions are valued.

Your Responsibilities:

• Resource for biological evaluation of changes to current manufacturing processes as well as new manufacturing processes for new product development;
• Biological Safety Risk Assessments and development of testing strategies for medical devices;
• Internal technical document creation and approval;
• Support complaints investigations, CAPAs, and other general technical support duties required within the team;
• Create Technical Reviews, specifications and other mandatory documents for regulatory submissions;
• Review and preparation of procedures to keep pace with standards development;
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings;
• Help to develop and generate material for staff training and data presentations;
• Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings;
• Educate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization;
• Provides support for key opinion leaders.

Profile of suitable candidate

• Has shown outstanding competencies as subject matter expert

o In depth knowledge of ISO 10993 standards and EU MDR

o Working knowledge of analytical chemistry

o Has a comprehensive record of external training in area of competence

o Prior experience with risk assessment of manufacturing materials

• Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter;
• Has experience in conveying complex scientific topics in a clear and comprehensible fashion;
• Able to effectively resolve conflict between two or more parties;
• Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner;
• Goes beyond existing knowledge base and expands our understanding, methods, and procedures, leaving a base for others to utilize and build upon (trailblazing);
• Demonstrates ability to balance needs of all departments to meet customer expectations and project schedules;
• Demonstrates an ability to utilize resources efficiently;
• Demonstrated ability to represent the company to accomplish objectives even during disagreements;
• Is professional, concise, and sensitive in accomplishing objectives. Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable;
• Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions;
• Handles discussions of complex topics with confidence ;
• Demonstrates ability to discuss sensitive information with and tailor communication style to listeners’ perspectives, including management, surgeons, and external contacts;
• Shows leadership skills and initiative.

Education:

• Minimum educational requirement is a MS in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology;
• Minimum of 4 years experience in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field required.

Travel Requirements

10%

Why this organization?

If you become a companies  team member, you can expect a career that challenges and stretches you, motivates and rewards you and supports and encourages you to reach your potential. They believe in the power of them, which means that they are stronger together and they are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

Salary

The company offers you a challenging position with good career prospects in a fast growing international business and a competitive remuneration package, good pension plan & bonus scheme.

How to Apply:

If you are interested and you meet all the above requirements please send your English resume via the 'Apply'  button or call for further inquiries to Noblesse Recruitment; Monique Nobel at +31 641 576 904 (www.noblesserecruitment.nl).