Nakisa H. Email & Phone Number

Stockholm, Se

Dublin, County Dublin, Ireland

- Reporting to the Chief Executive Officer (CEO), have oversight of Medical Device activities at NSAI (Ireland), NSAI Inc (US), and NSAI Certification UK and the MDR and IVDR designated Notified Body. - Embrace commercial responsibilities and direction as well as the strategic positioning of NSAI’s medical device capabilities in line with the needs of the Irish medical device sector, both established and emerging. - Responsible for ensuring the provision of efficient accreditation… Show more - Reporting to the Chief Executive Officer (CEO), have oversight of Medical Device activities at NSAI (Ireland), NSAI Inc (US), and NSAI Certification UK and the MDR and IVDR designated Notified Body. - Embrace commercial responsibilities and direction as well as the strategic positioning of NSAI’s medical device capabilities in line with the needs of the Irish medical device sector, both established and emerging. - Responsible for ensuring the provision of efficient accreditation services to national and international clients, and for ensuring that the certification service is delivered to the highest international standards. - Required to lead and direct a multidisciplinary team of clinicians, product reviewers, auditors, and support administrators as well as providing professional advice to the CEO, NSAI Executive Management Team and the NSAI Board, on new ways of capitalising on existing and emerging regulatory changes, including MDR and IVDR. Show less

Stockholm, Stockholm County, Sweden

- Leadership and coordination of all Area Nordics Supply Chain and Product (SCPA) Assurance Teams in Sweden, Denmark, Norway, Finland, Russia and Baltics for all Service Lines; ESG, Sustainability, Medical Devices, Product Assurance, Industrial and Aquaculture- Secure the Area Nordics P&L, Sales targets and Recruitment targets are accomplished - Regular reporting on Area Nordics P&L, Sales and Recruitment progress - Direct report of 7 FTE leaders with a total of 111 FTEs based in… Show more - Leadership and coordination of all Area Nordics Supply Chain and Product (SCPA) Assurance Teams in Sweden, Denmark, Norway, Finland, Russia and Baltics for all Service Lines; ESG, Sustainability, Medical Devices, Product Assurance, Industrial and Aquaculture- Secure the Area Nordics P&L, Sales targets and Recruitment targets are accomplished - Regular reporting on Area Nordics P&L, Sales and Recruitment progress - Direct report of 7 FTE leaders with a total of 111 FTEs based in Area Nordics. Show less

Stockholm, Sverige

Stockholm, Sweden

- Managing Director Intertek Medical Notified Body 2862- Head of Notified Body NB 2862 and Head of Notified Body NB 0413- Application, Joint Assessment and successful Designation of NB 2862 under the MDR- Leading NB 2862 to become the first MDR designated Notified Body in Sweden and 14th in Europe- Leadership of the global Notified Body NB 2862 and NB 0413- P/L (budget) responsible for the NBs 2862 and 0413- Chairing Management Meetings and leading the global NB… Show more - Managing Director Intertek Medical Notified Body 2862- Head of Notified Body NB 2862 and Head of Notified Body NB 0413- Application, Joint Assessment and successful Designation of NB 2862 under the MDR- Leading NB 2862 to become the first MDR designated Notified Body in Sweden and 14th in Europe- Leadership of the global Notified Body NB 2862 and NB 0413- P/L (budget) responsible for the NBs 2862 and 0413- Chairing Management Meetings and leading the global NB Management Team- Accountable for the performance of both NBs 2862 and 0413- Coaching and developing NB Management Team Show less

Stockholm, Sweden

- Managing the Notified Body for medical devices (Semko NB 0413) in Sweden- Expanding team from 6 FTE to 11 FTEs in less than 4 months

Denmark

- Managing Quality and Compliance group in Global Safety (14 employees) - Periodic reporting and presenting of summary data to top management and management groups- Responsible for key processes within Global Safety including- Pharmacovigilance System Master File- Quality processes including adherence to the Novo Nordisk QMS - Contracts and agreements with external partners and affiliates- Global compliance data- Audits and inspections- Ensuring KPIs are met… Show more - Managing Quality and Compliance group in Global Safety (14 employees) - Periodic reporting and presenting of summary data to top management and management groups- Responsible for key processes within Global Safety including- Pharmacovigilance System Master File- Quality processes including adherence to the Novo Nordisk QMS - Contracts and agreements with external partners and affiliates- Global compliance data- Audits and inspections- Ensuring KPIs are met within responsible processes - Chairing the annual Quality Management Review (QMR), following up on outstanding actions and escalating to higher level QMR where necessary- Promoting and raising awareness of the newly formed department, internally and externally- Coaching and developing team. Show less

Denmark

- Supporter to Business Areas Africa, Gulf and India, Germany, Oceana and South East Asia and the Region Europe Office in Zurich, including 40% travelling to these areas - Assist in the implementation, maintenance and improvement of the Novo Nordisk Quality Management System in Operations excluding Product Supply (PS), ensuring focus on business critical issues that may have an impact on NN license to operate and inspection readiness in these areas - Mediate contact between Quality… Show more - Supporter to Business Areas Africa, Gulf and India, Germany, Oceana and South East Asia and the Region Europe Office in Zurich, including 40% travelling to these areas - Assist in the implementation, maintenance and improvement of the Novo Nordisk Quality Management System in Operations excluding Product Supply (PS), ensuring focus on business critical issues that may have an impact on NN license to operate and inspection readiness in these areas - Mediate contact between Quality Affiliate and Marketing customers and HQ for resolution of various quality related issues- Perform self-inspections, internal audits in affiliates with less than 15 employees and external audits and support Region/Affiliate during internal ISO/GMP audits - Responsible for conducting Quality related courses and training for Operations excluding PS. - Train Regions’ business partners in compliance related matters in order to improve the quality level for handling of NN products at all steps in the distribution chain, as requested by affiliate - Member and representing Operations, excluding Product Supply in the following Subject Matter Expert Groups: Change Control, Non Conformities and Quality Management Review - Author of two top procedures related to Quality processes Show less

United Kingdom

- UK/Ire Business Area (BA) Quality Manager - Local Quality Responsible Person for the UK affiliate- Maintaining compliance to the Novo Nordisk Quality Management System for the BA (including ISO9001:2008)- Completion and monitoring of non-conformity, change control, annual audit and inspection, quality activity plans, quality management reviews and performing audits for the BA- Representing UK/Ire business area within REQMAN (Region Europe Quality Managers) and… Show more - UK/Ire Business Area (BA) Quality Manager - Local Quality Responsible Person for the UK affiliate- Maintaining compliance to the Novo Nordisk Quality Management System for the BA (including ISO9001:2008)- Completion and monitoring of non-conformity, change control, annual audit and inspection, quality activity plans, quality management reviews and performing audits for the BA- Representing UK/Ire business area within REQMAN (Region Europe Quality Managers) and Headquarters- Lead Auditor for internal and external audits including auditing against ISO 9001:2008, MHRA Orange Guide and Good Distribution Practice- Managing the Quality Team UK (four employees) and dotted line reports in Ireland (two employees) Show less

United Kingdom

Biomedical Sciences (Hons)

International Baccalaureate