Fenwal is a global leader in medical technologies focused on improving blood safety and availability for patient care.  A $600+ million business, Fenwal is a growing company that develops leading products, services and technologies used to collect, process and store blood and its vital components. Over 4000 people around the world work for Fenwal, helping each day to improve people’s lives while developing a rewarding career.

This position is located in our corporate office in Lake Zurich, IL

We currently have 2 new opportunities in our Regulatory Affairs area for Regulatory Specialists who will be responsible for preparing regulatory strategies and submissions for Fenwal products world-wide. One position will focus on drug submissions and compliance and the other will focus on medical device systems and software submissions and compliance.

Responsibilities include:

·         Represent regulatory on assigned product and project teams and establish regulatory strategies that align with world-wide objectives.

·         Execute regulatory plans for complex projects; develop and execute project plans for change control, new registrations and maintenance of existing licenses world-wide.

·         Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.

·         Provide assistance with responses to regulatory agency questions.

·         Review and approve product labeling and advertising for compliance to applicable regulatory requirements.

·         Support regulatory activities for government tenders.

·         Fulfill FDA export compliance requirements for area of responsibility.

·         Determine and communicate appropriate inclusion rules for import-export compliance.

·         Provide regulatory expertise and technical knowledge to fulfill complex post-market requirements.

Requires:

·                     Bachelor’s degree or equivalent experience in related scientific discipline

·                     5 years of related experience in regulatory affairs including experience in regulatory compliance and             quality systems

·                     US Drug submission experience required for regulatory position focusing on drug compliance

·                     Global regulatory experience preferred

·                     Excellent written and verbal communication skills

·                     Ability to think strategically, exercise independent judgment and problem solve

·                     Ability to independently identify compliance risks and escalate if necessary

·                     Experience working with project teams and acting as regulatory advisor

·                     Experience managing multiple projects and deadlines

·                     Proficient with Microsoft programs

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.