Medical Device Assessor / 医疗器械审核员

职位类别： 医疗器械推广专员

Key responsibilities &accountabilities

• Undertake management system assessments in accordance with BSI requirements.

• Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.

• Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.

• Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team

• Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.

• Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.

• Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.

• Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.

• Maintain and develop assessment skills and technical and management system standards knowledge. 

• Provide technical support to clients through business development, sales and customer service staff

• Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.



Candidate specifications



• Bachelor degree or above with medical related major or an equivalent professional qualification in a relevant subject and have a comprehensive knowledge of business processes and systems, *

• A medical device professional with training and a working knowledge of *

o ISO  & Medical Device CE Marking

o Medical Devices Risk Management – ISO 

o GHTF Basis Knowledge, Process validation, PMS & Vigilance 

• Minimum 3 years working experiences in the fields of medical device or in an area related to materials, manufacturing processes or design*

• Commercial understanding of compliance industry, minimum 2 years quality system management

• Knowledge of business processes and application of quality management standards

• Good verbal and written communication skills and an eye for detail

• Be self motivated, flexible, and have excellent time management/planning skills

• Can work under pressure

• Willing to travel on business intensively

• An enthusiastic and committed team player

• Good public speaking and business development skill will be considered advantageous

• Sufficiently fluent English skills both oral and written to allow: 

 a. Conduct of assessment visits in English plus understanding of related documentation.

 b. Receipt and understanding of all relevant training provided in English 

 C. Effective verbal and written communication in English with clients, regulators and BSI colleagues

• 年龄要求： 不限
• 语言要求：不限