Dieses Projekt wurde vom Anbieter geschlossen. Es sind keine Bewerbungen mehr möglich.

Archiviertes Projekt - RA specialist

Firmenname für PREMIUM-Mitglieder sichtbar

März 2020

September 2020

CH-Zürich

auf Anfrage

05.03.2020

RE-32877858_1583426041

Projektbeschreibung

Regulatory Affairs Specialist



Please see below the JD and Qualifications expected:



* In this function the position is responsible for all RA deliverables linked to the management with focus on orthopedic systems.
* The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US and CAN.
* This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation.
* He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.
* The RA specialist/manager will support international product registration by consulting the responsible RA manager for international projects.
* Assessing, approval and release of communication material (IFU, leaflets, brochures). Assist other departments to ensure continued compliance and timely market release.
* Support of product development in cross functional teams
* Creation, review and/or approval of documents of the design control process
* Accountable for regulatory compliance
* Support international product registration
* Assessment, approval and regulatory implementation of change requests
* Review and approval of product related labeling and marketing material
* Support SAP based reporting systems
* Training internally on relevant procedures and requirements

Qualifications

* Understanding of regulatory requirements, applicability and implementation in practice
* Understanding for product development process and principles of design control
* Understanding for quality system requirements
* Development, review and release of all documents required for technical files
* Interpersonal skills and multitasking
* Work in SAP and office and Google based programs
* Technical or scientific background, university degree is an advantage
* Good Knowledge of medical device legislation EU ,US and CAN and corresponding guidelines
* Good knowledge of product development processes in MD industry
* Good knowledge of quality system requirements such as ISO 13485 and FDA's 21 CFR Part 820
* Fluent in English, further languages are an advantage
* Highly organized and able to work under strict time lines
* Strong interpersonal skills and proactive working attitude in an international matrix organization
* Excellent writing and communication skills
* Experience in preparation for notified body audits and FDA inspections are an advantage
* Experience in managing cross functional projects and teams (RA manager position)
* Minimum 2 to 5 years experience in regulatory affairs within the Medical Device Industry (depending on the role)
* Experience with EU, US and CAN medical Device regulations

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

Kontaktdaten

Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.

Login

direkt bewerben:


Noch kein Mitglied?

jetzt registrieren »

Projektstatistiken

Projektstatistiken sind für PREMIUM-Mitglieder einsehbar.

Sie suchen Freelancer?

Schreiben Sie Ihr Projekt aus und erhalten Sie noch heute passende Angebote.

jetzt Projekt erstellen »