This position is located in our corporate office in Lake Zurich, IL
• Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations in APAC, EMEA and LATAM regions.
• Represent or lead the RA function on assigned cross-functional project teams.
• Monitor applicable regulatory requirements; assure compliance with Fenwal/Fresenius Kabi and external standards.
• Establish appropriate communication within RA and other functions at project and Internal levels.
• Perform gap analyses as needed and propose solutions.
• Develop and document sound regulatory decisions and justifications.
• Ensure project teams and business objectives and deliverables are aligned with regulatory strategies.
• Provide regulatory leadership to team,.
• Review promotional material or SOP’s for compliance with local and global regulations as needed.
• Bachelor’s degree or equivalent in scientific or related discipline
• 5+ years of regulatory experience in a medical device or pharmaceutical industry or directly related industry
• Working knowledge and experience with medical device and drug laws and regulations
• Ability to manage complex projects and timelines in a matrix team environment
• Demonstrated interpersonal skills including strong negotiation
• Strong oral and written communication and presentation skills
Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing.
Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce.
Fenwal - 2 years ago