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BSI

Global standards and business improvement partner

Client Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndonesiaNo salary listed

About the Job

Requirements

  • A bachelor degree or above with a medical-device-industry-related major, or a main professional qualification in a relevant subject, and comprehensive knowledge of ISO 13485 and EU medical device regulation.
  • At least 5 years of quality management and technology management experience in the specified medical-device fields: devices with biological active coatings or materials, or materials wholly or mainly absorbed or locally dispersed in the human body; active medical devices or active implantable devices; IVD devices manufactured using metal or plastic processing; or IVD devices manufactured using non-metal mineral processing such as glass, ceramics, textiles, rubber, leather, or paper.
  • Commercial understanding of the compliance industry and at least 2 years of quality system management experience.
  • Knowledge of business processes and application of quality management standards.
  • Good verbal and written communication skills and attention to detail.
  • Self-motivation, flexibility, and time-management and planning skills.
  • Ability to work under pressure.
  • Willingness to travel intensively for business.
  • Enthusiastic and committed team participation.

Responsibilities

  • Undertake management system assessments in accordance with BSI requirements.
  • Prepare assessment reports and deliver findings to clients, ensuring they understand the assessment decision and receive clear direction on corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures, and prescribed time frames.
  • Lead assessment teams as required, briefing team members to maintain service quality and effective working relationships with clients and within the team.
  • Establish and develop effective client partnerships that secure commercial relationships and encourage business development and increased client satisfaction across the portfolio.
  • Provide accurate and prompt information to support services, keeping client records up to date and complete and meeting internal information requirements.
  • Plan and schedule workloads to make effective use of time and maximize revenue-earning activity.
  • Coach colleagues, particularly inexperienced assessors or those unfamiliar with clients' businesses or technology, and assist with induction and coaching of new colleagues as requested.
  • Maintain and develop assessment skills and knowledge of technical and management system standards.
  • Provide technical support to clients through business development, sales, and customer service staff.
  • Represent BSI as a brand ambassador by acting ethically, following company rules, and promoting BSI services to help clients optimize business performance.
  • Deliver booked man-days on time and with good-quality work, while achieving positive client feedback.
  • Respond efficiently to client and internal queries.
  • Submit reports on time.
  • Actively solve problems when needed.
  • Add value for clients by identifying their needs and introducing multiple BSI services to improve business performance.
  • Help prevent customer attrition by providing quality value-added service and technical support.
  • Assess ISO 13485 quality management systems, EU medical device regulations, and the MDSAP scheme at customer sites; write comprehensive reports and present findings to clients.
  • Complete role training, including the ISO 13485 Lead Auditor course, MDSAP, and MDR.

Desired Qualifications

  • Good public speaking and business development skills.

About the Company

BSI

Global standards and business improvement partner

BSI is a global standards and business-improvement partner that helps organizations grow by addressing society’s critical issues, from climate change to trustworthy AI. It works by developing and applying standards, certifications, training, assessment, and assurance services that enable clients to manage risk, improve governance, and demonstrate compliance. Its products operate through a worldwide network of experts, industry groups, and governments, delivering audits, certifications, and advisory guidance to help clients meet specified requirements and improve performance. What sets BSI apart is its scale and breadth: a 100-year history, a global community of 15,000 experts and 77,500+ clients across many sectors, and a collaborative approach with regulators, industry bodies, and stakeholders to implement standards in real-world operations. The company’s goal is to help clients fulfil theirs by creating trust and accelerating progress toward a fair society and a sustainable world.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
1901

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