Regulatory Affairs Manager - IV Therapy

The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs.

** This is a hybrid position and requires working on-site 3 days per week in North Andover, MA.

Responsibilities

• Represent Regulatory on assigned product/project teams; establish and implement regulatory strategies that align with project objectives.
• Develop and execute regulatory plans for complex projects including new product. development, new registrations, product modifications, maintenance of existing licenses, and ongoing compliance activities.
• Strategize and prepare local and global regulatory submissions for assigned projects.
• Monitor applicable regulatory requirements for products within area of responsibility and inform product/project teams of upcoming changes in applicable regulations and guidance documents.
• Perform gap analyses and propose solutions to ensure compliance with local and global regulations as well as internal and external standards.
• Establish and maintain appropriate communication within Regulatory and across other functions primarily at project level.
• Develop and document sound regulatory decisions and justifications.
• Interact with regulatory agencies for assigned projects/submissions as directed by supervisor; respond to (or help with) regulatory agency questions within defined timelines.
• Review and approve product labeling and advertising/promotional materials for compliance with applicable regulatory requirements.
• Review technical documentation for suitability to support regulatory applications.
• Act as regulatory project manager on assigned projects. Collaborate with subject matter experts and drive project team to achieve established regulatory submission timelines.
• Mentor and train other regulatory staff.

Requirements

The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree with minimum of 6 years’ experience in a function such as regulatory, quality, or clinical in the life sciences industry.
• in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs).
• regulatory and scientific knowledge.
• and proven effective collaboration in a multicultural environment.
• oral and written communication and presentation skills.
• interpersonal skills including strong negotiation skills.
• to manage complex projects and timelines in a matrix team environment.
• to independently identify compliance risks and escalate when necessary.
• to lead and coach others.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.