Regulatory Affairs and Quality Assurance

A German medical device company, €2BN+ in revenues
Assumed the VP position for Regulatory Affairs during a management transition.

A Danish industrial corporation generating revenues of over € 3.5bn.
Undertook a RA&QA assignment for diabetes diagnosing & therapeutic devices. Risk Assessment, preparation for QS audit, critical software assessment and validation, support with spinning-off a branch of the company into a separate entity.

A Swiss start-up in regenerative medicine.
Structured licensing agreements, secure seed capital, developed their website, business plan and regulatory roadmap for theUS and Europe.

A Middle-Eastern surgical corporation with revenues of over $300m.
Undertook a RA&QA assignment to secure ISO 13485 certification of their largest EU subsidiary as a manufacturer of a range of products. Obtained the CE Mark of locally produced products for market authorization.

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