Heather Hagvik Email & Phone Number

Malmö, Skåne County, Sweden

Helsingborg, Sweden

Regulatory Affairs/ Compliance role. Working within Vigilance / Risk- MDVR reporting. International registrations. Design and development process as a legal manufacturer role within ISO 13485:2016. New product development within MDR. Notified body contact person. Deputy Manager, FDA knowledge, MDR QMS and MDR experience for the last 5 years with successful.

Helsingborg, Sverige

• Quality Assurance/Regulatory Affairs Professional with over 10 Years experience within the Medical device industry.
• International compliance including Quality System Regulation, Medical Device Directive, ISO 9001 and EN ISO 13485.
• International submission experience worldwide
• European Authorized Representative knowledge
• Supplier audits
• 10 year China work visa with multiple visits to site and understanding of China regulations

Helsingborg, Sverige

Submissions of class III implantable Medical devices in International countries. Coordinate International registrations with distributors and RA personal. Perform Internal and external audits.Renewals of International registrations, and legalization of documentation.

Ängelholm, Sverige

Product Managment, Key accounts, Inside Sales, Tenders. Follow regulations and standards ( ISO 13485) Monthly CAPA input based on complaint statistics.

Walnut Creek, California, Rocklin California

Venipuncture in a In / Out patient setting. Labeling and Collecting samples, spinning blood samples and planting cultures. Registering patients and having hourly hospital rounds.