Medical Device Consultant

Location

Remote | Canada

Job description

Our client, a leading MedTech company in Galway, is seeking a Medical Device Consultant to join their team. This is a brand new role that has been created in a growing company and they are seeking someone to grow with them. The Company is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide

The purpose of this job is to manage and complete consultancy activities in the field of medical devices in Ireland and other European markets as required. This role will include the completion of all activities related to preclinical safety, literature searches and client Regulatory requests/support. The role will contribute to the business development activities associated with the creation of
consultancy opportunities with diverse clients oriented towards market creation.

Responsibilities Include but are not limited to the following:

• Perform biological risk assessments, toxicology risk assessments and related activity to validate the preclinical safety of client medical devices.
• Support client regulatory requests though consulting and complete clinical assessment as required.
• Stay current and maintain level of expertise in ISO 10993 and regulatory requirements. Take opportunities to upskill and ensure awareness of emerging industry trends and expectations from Competent Authorities (e.g. US FDA).
• Ensure technical-scientific support to support customer assistance activities and be directly involved in the work on the project under responsibility.
• Set and maintain project timelines, escalate client concerns.
• To ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.
• To cooperate with the European Consultancy Group
• To communicate regularly with their team and all other ancillary groups to ensure information is transferred effectively throughout the organization. 
• Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas.
• To continually liaise with management, customers and other members of the organization on any relevant problem areas or enhancements to the business.
• To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
• Assessment of test requirements, methods and other client supplied study specifications and information in conjunction with Project Management, Pricing Group, and other functions to help design service solutions that meet clients’ requirements.
• Overall responsibility for the provision of on time, high quality proposals that present the optimum solution for the client whilst ensuring on or above plan profitability.
• Reporting – provision of account, activity and market status reports as required on a local or global basis as appropriate.
• Continuous improvement – identification of opportunities for improvement of quality and service with client group, formulation and implementation of action plans for continuous improvement
• Support the business in the establishment of a test facility to deliver services as outlined by management

• Preferably 3 – 5 years’ experience in a medical device industry
• Experienced Risk assessor (3 – 5 years).
• Good commercial awareness and business acumen.
• Business Development Exposure and understanding ( 3-5 years)
• Excellent communication skills. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.
• BSc or MSc in Biomedical Engineering;
• Experience of at least 3 years in regulatory and/or testing related to Medical Devices in biocompatibility and/or toxicology.
• Experience of ISO 10993 series , tools for toxicological assessment and processes relating to biological assessment/evaluation.

Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies

Pale Blue Dot ® Recruitment
The Resource for the MedTech Workforce

Job tags

Salary