Experience

Nanovi A/S

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director, Regulatory Affairs

  • May 2018 - Present

• Senior Regulatory Affairs Manager

  • Sep 2016 - May 2018



Coloplast

• Denmark
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Manager

  • Dec 2015 - Aug 2016

  Previous tasks continue in the senior position, with emphasis on:- Driving optimisation of processes and workflows.- Allocation of team resources to product registrations. - Being a regulatory sparring partner to managers and regulatory affairs teams.

• Regulatory Affairs Manager

  • Feb 2013 - Nov 2015

  Maintenance of product documentation for EC class I-III medical devices (wound care products, incl. OBL, continence care products and ostomy care products). Risk Management and Design Control activities, incl. evaluation of regulatory impact of product changes. Contact to notified body in regards to re-certification of class III medical devices, change notifications and preparation of dossier for supplementary consultation to competent authority, MHRA. Gathering regulatory intelligence worldwide, incl. Europe, Brazil, US and Asia Pacific with primarily focus on China and South Korea.Making regulatory strategies and supporting market expansions worldwide, incl. preparation of registration files and driving the regulatory part of internal market expansion planning process. Supporting in technical file audits and manufacturing site audits (on-site and/or paper audits) performed by notified bodies and authorities worldwideProviding regulatory consultancy e.g. in cross functional projects. Review and approval of technical documentation for class I to class III devices, including marketing material, labels, IFUs and biological evaluations. Provide training. Show less



Kalundborg Svane Apotek

• Pharmacist

  • May 2012 - Jan 2013

  - Managing daily operation and distribution. - Screening of prescriptions and intervention. - Training and coaching the staff. - Distribution, instruction and counseling of medicines. - Managing daily operation and distribution. - Screening of prescriptions and intervention. - Training and coaching the staff. - Distribution, instruction and counseling of medicines.



Faculty of Pharmaceutical Sciences, University of Copenhagen

• Denmark
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Master in Pharmacy (Cand. Pharm)

  • Sep 2006 - Feb 2012

  Bachelor & Master in Pharmacy Bachelor & Master in Pharmacy



Lægemiddelstyrelsen (Danish Medicines Agency)

• Denmark
• Government Administration
• 400 - 500 Employee

• Assistant - Consumer Safety Division

  • Aug 2008 - Oct 2011

  - Assessment of national PSURs, - Collaboration with international agencies in the assessment of Worksharing PSUR. - Communication of requirements to SmPCs to medicinal industry. - Acknowledging PSUR submissions and collecting PSUR fees - Ad hoc tasks within Pharmacovigilance - Assessment of national PSURs, - Collaboration with international agencies in the assessment of Worksharing PSUR. - Communication of requirements to SmPCs to medicinal industry. - Acknowledging PSUR submissions and collecting PSUR fees - Ad hoc tasks within Pharmacovigilance



Niels Brock

• Denmark
• Education Management
• 300 - 400 Employee

• Student

  • Feb 2006 - Jun 2006

  HHX HHX


Næstved Gymnasium & HF
• Primary and Secondary Education
• 1 - 100 Employee
• Student

  • Sep 2002 - Jun 2005