Mgr Regulatory Affairs-Front Line Care – Flc

Mgr Regulatory Affairs-Front Line Care – Flc

Requirements

• Bachelor’s degree or country equivalent in a scientific field.
• 5+ years or more of experience in RA or related field (preferably medical device or pharmaceutical), including people management or projects.
• Ability to work effectively in multinational/multicultural environment
• Sound basis of Scientific (Training/ Communications) knowledge
• Ability to oversee multiple projects in a matrix team environment
• Excellent oral and written communication and presentation skills
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities

Responsibilities

• Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.
• Represent or lead the RA function on assigned cross-functional project teams.
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards.
• Establish appropriate communication within RA and other functions primarily at project level.
• Perform gap analysis and propose solutions.
• Develop and document sound regulatory decisions and justifications.
• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
• May provide direct supervision of individuals.
• May review promotional material or SOP’s for compliance with local and global regulations.

Preferred Qualifications

• Masters and/or PhD will be an advantage.
• Experience with Class II and Class III EU device is preferred.
• Experience with EU MDR preferred.
• Experience with the US 510k submissions strongly preferred.