Senior Regulatory Affairs Specialist, EMEAI

Please apply through our career portal: www.beckmancoulter.com

REF. 1782 BR

Only applications received through our portal will be taken into consideration.

Simplify – Automate- Innovate

Beckman Coulter simplifies and automates laboratory processes used in all phases of the battle against disease. The company produces systems used around the world in biomedical analysis and pioneering medical research to speed drug discovery and perform diagnostic tests to manage patient care. A market leader with $3.7 billion in sales and with operations in more than 130 countries world-wide, we’re growing fast. As innovating solutions begin with an understanding of our customers’ needs, we are dedicated to finding new ways to meet their challenges.

Are you a professional that enjoys working in a multicultural environment? Join our Headquarter based in Nyon as a

Senior Regulatory Affairs Specialist, EMEAI

NATURE AND SCOPE

Pre-Market Regulatory
• Support / prepare subsidiaries and distributors with the product registration in different area of EMEAI
• Communicate regulatory requirements to appropriate regulatory teams, development centers and other affected units

• Monitors change in the regulatory environment in EMEAI, evaluate impact and communicate to interested parties in conjunction with distributors and RA personnel in the subsidiaries
• Support sales and marketing teams with regulatory documents 

    • Support implementation of Environmental Directive requirements and Hazardous chemical

regulations in EU subsidiaries and in Business Centers

• Review marketing materials (ad/promo materials, presentations, etc) for suitability for EMEAI markets and accuracy against the sources.

• Provide training on different regulatory topics to sales, marketing, technical service, customers service and logistic as well as to RA personnel in subsidiaries and distributors

• Ensure compliance of regulatory procedures with current regulatory requirements and communicate to the appropriate personnel.

Post-Market Regulatory
• Inform subsidiaries and distributors on product corrective actions
• Support subsidiaries and distributors in the implementation of product corrective actions and vigilance reporting according to applicable regulations and internal company procedures
• Maintain vigilance and traceability documentation on performed product corrective actions and vigilance reporting            

• Monitor the product corrective actions with the distributors and subsidiaries to close them within established timeframe.

KNOWLEDGE / EXPERIENCE REQUIREMENTS

• 6 years in medical device Regulatory Affairs experience
• A Life Science / technical background required
• Understanding of regulatory requirements in EMEAI countries
• Understanding of IVDD 98/79 and Environmental Directives (WEEE, RoHS,Batterydirective, Packaging waste, REACH
• An understanding of Quality System requirements according standards like ISO 13485 and/or ISO 9001.
• Fluent in spoken and written English is a must, any additional language an advantage
• Excellent communication, analytical and  interpersonal skills
• Extensive IT Skills, experience with Medical software is an asset.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at www.beckmancoulter.com

Please apply through our career portal: www.beckmancoulter.com

REF. 1782R

• Schweizer Bewilligung / C / B / G / EG-Europäische Staatsbürger

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