Regulatory Affairs Specialist - Medical Devices

LOCATION: OBERDORF

SALARY: NEGOTIABLE

CONTRACT LENGTH: 12 MONTHS (INITIAL PERIOD, MAY BE EXTENDED).

A pioneering Medical Device company is seeking to appoint a Regulatory Affairs Specialist. The appointed candidate will be drawing on relevant expertise and information from internal and external sources and making a major contribution towards the preparation of regulatory documentation (eg Technical Files).

Responsibilities:

- Support the internal Regulatory Affairs group in creation and maintenance of TECHNICAL FILE DOCUMENTATION
- Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory requirements.
- Reviewing of labeling and promotion material for accuracy and consistency.
- Ensuring that the company's products comply with the regulations of government agencies, including but not limited to:

Keeping abreast of international legislation, guidelines and customer practices. 
Collecting and collating a wide range of information. 
Keeping up to date with a company's product range. 
Developing and writing clear arguments and explanations for regulatory documentation 
Advising scientists and manufacturers on regulatory requirements. 
Reviewing change requests 
Reviewing, preparing and coordinating documentation. 
Reviewing company practices and providing advice on changes to systems.

Requirements:

Expertise of Regulatory Affairs, including:

- Profound knowledge of EUROPEAN MEDICAL DEVICE REGULATIONS, especially COUNCIL DIRECTIVE 93/42/EEC
- Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
- 2-3 YEARS OF EXPERIENCE IN MEDICAL DEVICE REGULATORY
- Familiarity with TECHNICAL DOCUMENTATION STRUCTURE ACCORDING TO STED
- Technically versed in computer software such as MS Word, Excel, Powerpoint,
- Strong database skills (Access) desired.
- Strong analytical skills and network thinking
- Be able to demonstrate driving partnerships within the industry.
- Proven ability of interpreting legislation and impact to meet commercial needs.
- Proven capability of successful working relationships with regulatory bodies.
- Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions. Excellent communication and interpersonal skills, ability to influence.
- Proven success at managing and driving a team to meet strategic goals and KPIs
- Excellent attention to detail.
- Degree or equivalent in a Life Science.
- Excellent communicator, both verbal and written.
- Working knowledge of Windchill, Agile, SAP etc)

Language skills:

- Excellent command of English and German.

Please send CVs or call.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.