Regulatory Affairs Manager - MED-EL Elektromedizinische Geräte GmbH - Innsbruck - Austria

Job Description:
The Regulatory Affairs Manager is the primary contact person for development, preparation, and submission of product approval applications and notifications to regulatory agencies and governing bodies for all products produced and/or distributed by our company.
As a working manager, the RA Manager provides, or directs other RA personnel to provide, input to product development projects regarding regulatory strategy, regulatory requirements and related company requirements.
The RA Manager is responsible for assuring that all procedural requirements of the Corporate Regulatory Affairs Department in Innsbruck are fulfilled and provides input to global regulatory strategies and policies.

Qualification and skills:
Working experience (approx 5 years) with medical devices regulatory submissions for approvals and registrations which meet the requirements of MDD, AIMD, FDA, Health Canada, MHLW, sFDA, etc. Must compile regulatory submissions; a do´er plus a team leader.
Expert level of knowledge of EU, US FDA, Canadian, Japan, China, Korea regulatory requirements and submissions process.
Ability to formulate regulatory strategies for global market approvals and present them to Senior Management.
Demonstrated leadership of a regulatory team. Manage task assignments and status reviews.
Demonstrated organization skills to manage all aspects of regulatory affairs on a daily basis. Includes interface with Senior Management, R&D, Marketing, Product Management, etc.
Experience and capability to interface with Subsidiaries and Sales Offices regarding regulatory questions.
Knowledge of and experience with regulatory requirements for clinical studies.
Knowledge of regulatory requirements for labelling and country language requirements.
Ability to be the primary interface with US FDA and TÜV regarding pre-submissions discussions, submissions, and post-submission resolution of questions.
Professionalism and seniority to represent the company at conferences, technical meetings, and association meetings.

MED-EL is a fast pace and high-tech company specialized in implantable medical devices. We design, fabricate, and distribute cochlear implants and other neuro stimulation products. The company is located in scenic Innsbruck, Austria. For more information check our website at www.medel.com. We look forward to receiving your application via e-mail to: jobs@medel.com.

Worldwide Headquarters
Fürstenweg 77a
A-6020 Innsbruck
Austria
Tel: +43(0)512 288889
Fax: +43(0)512 293381