Junior regulatory affairs application – Baxter Europe

Regulatory affairs associate application – Europe
Job number 15247

Job: Regulatory Affairs
Primary Location: France, Lyon
Organization: Global Regulatory Affairs
Schedule: Full time
Job Posting: 14/09/2015
Unposting Date: 31/11/2015


Job Title: Regulatory Affairs Associate

DESCRIPTION
Baxter is a global company dedicated to manufacturing and marketing products that save and sustain the lives of people with infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
The Regulatory Affairs associate will be part of the European regulatory team with primary responsibility for supporting all regulatory activities associated with the registration and optimal lifecycle management of the Baxter device portfolio enabling optimal delivery of the commercial objectives in these countries.
The European Regulatory group is accountable for the relationships with European legislation, along with other relevant regulatory bodies. It provides input and influences global regulatory strategies and is responsible for the local execution of Baxter’s regulatory initiatives in line with European business goals. The team is composed of approximately 30 staff across two locations (Lyon and Guyancourt).

KEY TASKS & RESPONSIBILITIES
This position is responsible for managing various regulatory licensing activities for new products under development. Examples include, but are not limited to:
• Write domestic medical device regulatory submissions/licenses including Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, Amendments and Regulatory authority responses.
• Support the Manager of Regulatory Affairs in device regulatory strategy through participation in meetings, design control activities/projects.
• Support Manager of Regulatory Affairs in review of device regulatory submissions for IP products.
• Work with functional representatives from other areas such as Clinical, Pharmacovigilance and R & D to review and provide input on documents such as PSURs, Investigator Brochures etc.
• Partner with Global Regulatory Franchise teams to guide relationships with regulatory authorities and facilitate interactions on behalf of Baxter
• Accountable for ensuring that regional regulatory submissions meet appropriate standards and content requirements
• Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans

QUALIFICATIONS
• Advanced Degree or country equivalent in science-related field.
• Minimum of 1 year in medical device industry.
• Strong technical knowledge of device labeling contents and regulatory requirements.
• Strong knowledge and interest in the evolving landscape of labeling regulations, including serialization requirements for devices

COMPETENCIES
• Excellent organizational and effective communications skills
• Teamwork
• Problem solving ability
• Multi task ability
• Comprehensive coordination and compilation of documentation
• Be able to execute defined projects with minimum management guidance
• Windows based applications: MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat.

APPLY ONLINE – CLICK HERE

Dear Ms ...,

I am a biological engineer looking for a position in Regulatory Affairs.
I am currently studying a master’s degree in Medical Devices Regulatory Affairs and working as a trainee within a famous Medical Devices company.
The missions you describe in your job offer meet my expectations and correspond to my background. Therefore, I am writing to express my interest in working in your company.

I remain at your entire disposal if you require any further information.

Best regards,

Nathalie Portanova