1. Mark Walker Senior Compliance & Regulatory
Engineer
+86 18410433912 bertwalker2005@yahoo.co.uk Apt. 3702 Tower A Phoenix City Beijing, China
100028
Senior Compliance and Regulatory Engineer, with more than 30 years of experience In Medical
device industry. Expert in all new EU new approach directives applicable to medical devices, and
3rd edition standard for Medical devices. Specialist in ETL/UL Listing protocols. Expertise in
identifying and mitigating potential problems. Experienced in developing and implementing
innovative approaches to achieving compliance and meeting international standards. Adept in
directing development and implementation of Regulatory strategies. Broad knowledge of world
standards, with expertise in rhw Medical field including 60601-1 and, IEC 60950, 1010 and
assessments for Semi standards S2 and S8. Proficient in supporting internal local and Global
audits. Skilled in client relationships across industries including health care, pharmaceuticals,
research, telecommunications, national government, and all test house related industries.
Practiced in identifying and mitigating possible problems. Areas of Expertise include:
*IEC/UL Standards *European Directives *Compliance
*UDI Implementation *NB Audit Support *Personnel Training
*Research & Development *Purchasing *Risk Assessment
*Client Relationships *Project Management *Negotiations
*Quality Assurance *Business Process Enhancement *Supply Chain Compliance
Experience & Notable Contributions
ELEKTA LTD February 2002-Present (Uk and china based, permanent China from 2011)
Senior Compliance/Regulatory Engineer
In-house expert in compliance leading all efforts to ensure adherence to regulations;
instrumental to meeting compliance to 60601-2-1 and 60601-1 3rd edition compliance. Expert
in UDI/AIDC compliance, Direct Global UDI regulatory implementation. Solve supply chain
compliance issues in China and across Europe. Established and trained RA team in Asia Pacific.
Instrumental in Elekta China getting its 1st
CE marked Linear accelerator. Collaborate in
development of international product standards. Support local business units and global supply
chain compliance. Instruct employees in redesign, V&V, regulatory compliance and project
management. Manage RA and QA for various product releases. Supporting all BAOS (global
Elekta) functions on worldwide approach to standardization and directives. Dynamic integrator
with test houses.
Key Accomplishments:
*Created the first intergrated standard for Elekta Synergy the first ever cone beam CT Device
*Identified need and commercial advantage of an Integrated Automatic Information Data
Capture System. Drove UDI Compliance program.
*Directed efforts resulting in 60601-2-1 and 60601-1 3rd edition compliance in UK and China.
*Brought China device into compliance, guiding supply and R&D.
*First ETL/UL Approved linear accelerator.
*Wrote RA standards program to achieve Industries 1st
Cone beam CT linac

2. ITS TEST & CERTIFICATION LTD Leatherhead, UK 1998-2002
Senior Medical and Site Engineer June 1998 – February 2002
Evaluated electrical and electronic compliance to applicable world standards on a broad range
of products. Project Manager for clients including Magnex Scientific, GE, Elekta Oncology,
Tandberg, and BOC-Edwards. Key to UL, EN and IEC listing and Certification processes for my
clients. Key point of contact for international clients.
Medical Test Engineer February 1998 – June 1998
Tested all medical devices against company and industry standards. Developed valuable
relationships with clients, providing top quality customer service. Promoted to Senior Medical
and Site Engineer due to positive client feedback.
MAGNEX SCIENTIFIC LTD Abingdon, UK 1995-1996
NMR Service Engineer
Commissioned all NMR magnet systems in Europe, the United States, and Asia. Tested NMR
Magnets for Medical use. Ensured test equipment complied with World Standards.
OXFORD INSTRUMENTS Oxford, UK 1979-1995
Manager 1987-1995
Developed test laboratory working practices, used as basis for proposal for ISO 9001 awarded to
the company by British Standards Institute. Trained and evaluated staff members. Cultivated
relationships with account holders. Managed resolution of any technical problems.
Senior Test Engineer 1984-1987
Developed relationships with and managed service for clients and sales personnel.
Test Engineer 1982-1984
Directed testing of all solenoid types.
Trainee Engineer 1979-1984
Tested all Oxford NMR Superconducting magnet system to full specifications, including all
wiring solenoids, energising,
checking field drift, homogeneity, and cryogen boil-off rates.
Education & Training
City & Guilds 224 in electronic servicing (Level 1 & 2)
NEBMS Industrial Supervisor/Manager Course (one-year modules).
Edwards High Vacuum Leak Detection Course
Industrial Society 3 Day Residential (Leadership role of a working chargehand)
Marcus Bonn Service Engineering (as a company ambassador) course.
ERA Technologies Risk assessment as a Design Engineer (1 Day)
Metron Course looking at new regulations on real Earth Leakage

3. ETL Project management training for product safety engineer.
Synergus course on medical device software use of IEC 62304
FDA Quality System Regulations 21 CFR part 820
IEC 60601 Conference regarding IEC 60601-1 3rd Edition
ISO 14971 Risk Management in Medical Devices, BSI
GHTF Conference for “Design for Patient Safety
1st line Training course for Precise Treatment Systems.
Project Process Training, Oxford Projects
CIMDR in Xiamen, Xian, Guangzhou