Manager, Regulatory Affairs - Boston, United States - Fresenius Kabi

Description

Job Summary 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 objectivesDevelop and execute regulatory plans for complex projects including new product development, new registrations, product modifications, maintenance of existing licenses, and ongoing compliance activitiesStrategize and prepare local and global regulatory submissions for assigned projectsMonitor applicable regulatory requirements for products within area of responsibility and inform product/project teams of upcoming changes in applicable regulations and guidance documentsPerform gap analyses and propose solutions to ensure compliance with local and global regulations as well as internal and external standardsEstablish and maintain appropriate communication within Regulatory and across other functions primarily at project levelDevelop and document sound regulatory decisions and justificationsInteract with regulatory agencies for assigned projects/submissions as directed by supervisor; respond to (or help with) regulatory agency questions within defined timelinesReview and approve product labeling and advertising/promotional materials for compliance with applicable regulatory requirementsReview technical documentation for suitability to support regulatory applicationsAct as regulatory project manager on assigned projects.

  Collaborate with subject matter experts and drive project team to achieve established regulatory submission timelinesMentor and train other regulatory staffRequirements Bachelor's degree with minimum of 6 years' experience in a function such as regulatory, quality, or clinical in the life sciences industry, OR high school diploma with minimum of 8 years' experience in medical device or pharmaceutical regulatory affairsExperience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs)Sound regulatory and scientific knowledgeExperience and proven effective collaboration in a multicultural environmentStrong oral and written communication and presentation skillsDemonstrated interpersonal skills including strong negotiation skillsAbility to manage complex projects and timelines in a matrix team environmentAbility to independently identify compliance risks and escalate when necessaryAbility to lead and coach othersAdditional 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, andwellness 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.

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