Regional Regulatory Affairs Lead in Schaffhausen

veröffentlicht
Kontakt
Raphaël Brandt, Randstad HR Solutions
Jobtyp
Permanent
jetzt bewerben

job details

veröffentlicht
Ort
Schaffhausen
Sektor
Life Sciences
Jobtyp
Permanent
Referenznummer
205639-9
Kontakt
Raphaël Brandt, Randstad HR Solutions
Telefon
062 517 71 68
jetzt bewerben

Stellenbeschreibung

For our client ASP / Fortive, we are looking for a 100%

Regional Regulatory Affairs Lead, EMEA

Tasks :

The Regional Regulatory Affairs Lead role provides local support and leadership for registration and licensing requirements as they apply to products and services of the company both domestically and internationally, as well as facility licensing activities pertinent to EMEA.

Ensures international vigilance processes and management for Product Surveillance (distributor and direct sales and service) are relevant, effective, and maintained. Collaborates with and provides oversight to local RA Strategists on the preparation of submissions to local RA health authorities as well as formulating and implementing regulatory strategies to assure timely global commercialization of products in compliance with applicable regulations and standards. Plans, creates, and maintains the regulatory dossiers ('Technical Documentation') in line with changing national and international regulatory demands.

Qualifikation

  • A Bachelor's Degree from an accredited college or university is required. A degree in science, biomedical engineering, medical / scientific writing, public health administration is preferred. An Advanced Degree (e.g. M.S., PhD, etc.) is preferred.

  • Must have 7+ years of business experience and 5+ years working in Regulatory Affairs.

  • Knowledge of relevant medical device laws, regulations, guidelines and standards, in particular, but not limited to the European Medical Device Directive / Regulation as well as FDA 21 CRF Part 820, and implements via suitable processes.

  • Must have successful track record of supporting project teams and preparing submissions for Class II and Class III medical devices.

Interested ? Please send complete file to : raphael.brandt@randstad.ch or call ++41 79 748 96 49 for more information.