Regulatory Service Client Manager

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Position: Client Manager (Auditor)

Purpose of the role:

As the face of BSI, the role of the Client Manager Medical Devices is to work closely with BSI clients across the Globe. The role is based in Japan, helping clients to improve their performance by assessing their Quality Management Systems and related processes against BSI standards and legal requirements such as the Medical Device Regulations. At the end of each assessment the Client Manager compiles an assessment report and presents this to the client. This role operates predominantly within the highly regulated medical devices market.

Key Responsibilities & Accountabilities:

Ensure that value is added to customers and their business/organisation through the assessment of their systems and processes against BSI requirements
Complete assessments and visit reports compliantly and in line with BSI requirements
Recommend the issue, re-issue or withdrawal of ISO 13485, ISO 9001, CE and MDSAP certificates, and report recommendations in accordance with BSI policy, procedures and timeframes
Continuously enhance and uphold BSI’s reputation through effective planning, service delivery, compliant reports, and positive interactions with clients and key stakeholders
Demonstrate commercial acumen and providing added value in client interactions
Maintain a professional and engaging demeanour in all client relations, ensuring a positive and constructive experience
Lead assessment teams as required, ensuring team members are well-briefed to maintain quality of service fostering effective working relationships
Build and nurture strong partnerships with clients, securing long-term commercial relationships and identifying opportunities for business development and increased client satisfaction
Provide accurate and timely information, ensuring client and other records are up to date and complete, whilst adhering to internal information requirements
Plan/schedule workloads to make best use of own time and maximise revenue-earning activity
Maintain and enhance appropriate professional qualification status in relevant disciplines
Support induction, training, development, coaching and qualifying reviews where requested
Be an active member of the Operational Delivery Team, proactively engaging with peers and key stakeholders to ensure continual improvement, in line with the BSI standards of Assessor Excellence putting the customer first

Key Performance Indicators:

Customer Focus

Able to effectively assess QMS systems across a wide range of Medical Device Manufacturers
Able to solicit, interpret and use information about the clients needs and expectations to add value
Is recognised as a medical device and sector expert; provides support and expertise to enable continual improvement
A brand ambassador of BSI, taking pride in their role and delivering on commitments

Operational Delivery

Organises work and executes to BSI’s standard of excellence and takes responsibility for resolving unexpected issues
Can proactively deal with issues through to resolution
Able to communicate effectively with senior audiences, peers, stakeholders and customers to engage and motivate
Delivers to all compliance requirements and BSI’s standards of excellence

Communication

Has clear and unambiguous communication style that avoids unnecessary jargon
Is a credible and stimulating communicator, able to adapt their style to best serve the clients needs
Creates a positive & engaging experience for clients , helping them to embed excellence

Commercial Awareness

Can articulate to clients the findings from their assessment and how improvements link to business performance
Engages clients on their wider needs, offering suggestions for other BSI products and solutions
Can qualify sales leads appropriately and pass on to relevant sales teams
Understands the revenue impact from activities in which they are engaged / responsible

Travel requirements:

This position requires travel to and from clients

Language requirements:

Business English
Local language proficiency as required by the specific post location

Knowledge and Experience:

At least 4 years of full-time work experience in the medical device industry, including a minimum of 2 years in one or more of the following areas:

Related industries such as research and development or manufacturing
Application of device technology in healthcare services and patient care
Testing devices for compliance with relevant national or international standards
Conducting performance testing, evaluation studies, or clinical trials of devices
Regulatory or professional services experience

Skills and Abilities(e.g. Teamwork,IT, Communication,Relationships):

Excellent verbal and written communication skills with strong attention to detail
Ability to work independently, adapt to changing circumstances, and manage time effectively
Capable of performing well under pressure
Willingness to travel frequently for business purposes
An enthusiastic, committed team player
Ability to deliver superior performance and achieve challenging objectives
Proactive and able to lead by example
Demonstrates a strong passion for the business and the ability to inspire others

Qualifications(e.g. Technical):

Degree-level qualifications relevant to medical devices (e.g., electrical, mechanical, or bioengineering; biology or microbiology; chemistry or biochemistry; computer and software technology; human physiology; medicine; pharmacy; physics or biophysics)

Personal Qualities /Aptitudes(e.g. Initiative, flexibility,commitment,reliability):

Conducts business ethically and with integrity
Understands client needs and adds value through commercial insights

BSI Excellence behaviours:

Client Centric – I put internal and external clients at the centre of my thinking. I am proud to deliver outstanding client service.
Collaboration – I build trust-based relationships through my ability to communicate openly and honestly. I value what others bring and I work inclusively with others at all times.
Agility - I am open to change and willing to adapt my ways of working. I explore new ideas and ways to improve things to grow the business effectively.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

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