Senior Specialist, Regulatory Affairs

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products.

Collaborate in maintaining the quality system documentation processes and procedures adopted by the company.

Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.

Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.

Support the regulatory submissions for market authorization for medical device products.

Facilitate the approval process for software releases.

Disseminating knowledge about the Quality System and regulatory requirements.

Oversee post-market surveillance activities related to medical device products.

Networking / Key relationships

Factory Lead and Solution Leaders

A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector

Knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..).

Knowledge and experience working in Medical device software life cycle process (IEC 62304)

Knowledge and experience working in medical device regulatory submissions (MDR / IVDR,FDA..)

Good level of Technical and Conversional English.

A meaningful project that will impact the quality of laboratory software medicine worldwide

~3 days a week working from home

~ Exciting opportunities for professional development.

~ Ongoing training

~ Social benefits : Canteen, nursery check, English training...