Regulatory Affairs & Quality
Anders Skoglund

 

About Me

Senior regulatory affairs & quality assurance professional in the medical device industry. Significant experience with international regulatory, compliance, and quality systems requirements. Experienced leader for both FDA and Notified Body inspections. Demonstrated skills in obtaining regulatory marketing clearance, attaining regulatory compliance, developing quality systems, and working with cross-functional teams. A highly credible and respected leader and team player with strengths in problem solving, influencing, evaluating, planning and communicating.

Key Highlights

Success working with multifunctional teams comprised of Engineering, Marketing, Quality Assurance, and Manufacturing to register new products globally.

Understanding of the intent and objectives behind regulations and knowledge of how to operate within that framework.

Progressive responsibilities in Regulatory Affairs, Quality Assurance, departmental management, worldwide corporate leadership, and financial planning spanning several companies.

Recognized for ideas and team leadership, innovation, consensus building and meeting regulatory requirements.

  • Name Anders Skoglund
  • RoleSenior Vice President Regulatory Affairs & Quality
  • LocationStockholm, Sweden
  • Websitewww.andersskoglund.com
"predictable and sustainable market access"
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Languages

  • Swedish
  • English
  • German
  • Japanese

Core Compentencies

  • Medical Device Regulations
  • Quality System Regulations
  • Adverse Event Reporting Regulations
  • Radiation Safety & Security
  • Medical Device Standards

Experience

Senior Vice President Regulatory Affairs & Quality

Elekta 2019 - present

Leading the Regulatory Affairs & Quality function within the Elekta Group. The function consists of approximately 120 persons with 14 direct reports.

Vice President Regulatory Affairs

Elekta, 2016 – 2019

Leading the Regulatory Affairs function within the Elekta Group. The Regulatory Affairs function consists of five groups, Market Access, Regulatory Governance, Post Market Surveillance, Radiation Safety & Security and Regulatory Affairs. Approximately 60 persons with 8 direct reports.

Vice President, Global Regulatory Affairs

Elekta, 2010 – 2016

Leading the Global Regulatory Affairs support function within the Elekta Group.

Director Regulatory Affairs

Elekta, 2008 – 2010

Leading the Regulatory Affairs department at Elekta Instrument AB (Business Area Neuroscience).

Regulatory Affairs

Elekta, 2003 – 2008

Responsible for development and maintenance of authority approvals i.e. technical files for CE-marking, 510(k) applications for USA, technical documentation for Canada, China, Japan, Taiwan, Thailand, and rest of world including application for transportation, service, and handling of radioactive materials.

Manager Complaint Handling

Siemens-Elema AB, 2002 – 2003

Leading the Complaint Handling, Test & Production Technique team with 13 direct reports, 7 complaint handlers, 3 test engineers and 3 production engineers.

Senior Manager Regulatory Affairs

Siemens-Elema AB, 1998 – 2002

Responsible for development and maintenance of authority approvals i.e. technical files for CE-marking, 510(k) applications for USA, technical documentation for Canada and Japan.

Project Engineer

Intertek, 1993– 1998

Testing of medical devices for S-marking, compliance to standards and/or compliance to the medical devices directive (MDD). Testing for countries outside Europe i.e. Canada, Japan and USA. Testing and investigations of laboratory equipment for compliance to standards and/or directives i.e. the low-voltage directive.

Bio-medical Engineer

Stockholms Läns Landsting, 1988 – 1993

Service and maintenance of medical devices from most of the departments in the hospital but with a focus on intensive care department, heart intensive care department, anaesthesia department, OR and wards serving OR.

Skills

  • Broad experience of regulatory affairs, quality assurance, authority communication and standardization.
  • Excellence ability to work in a multi-cultural environment.
  • Well organized.
  • Result oriented: Ability to achieve the target within given time.
  • Excellence communication skills.
  • Negotiating skills.
  • Conflict resolution.
  • Analytical thinking. Data driven management.