Regulatory Affairs Manager

Responsibilities :

Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.

• This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems.
• This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programs.
• Develops sound global regulatory strategies for new and modified medical devices.
• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams.
• Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
• Provides global strategic input to development teams (including all feasible alternatives and associated risks).
• Drives cross functional alignment with issues that could have Regulatory ramifications.
• Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies).
• Builds strategic partnerships to further departmental and organizational objectives.
• Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).
• Reviews protocols and reports to support regulatory submissions.
• Assesses proposed regulations and communicates new requirements to the organization.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education and Experience :

• Bachelor's Degree OR an equivalent combination of education and experience.
• 8+ years technical experience.
• 6+ years medical device regulatory experience.
• Extensive experience with US and global medical device regulations and submissions.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to multi-task, prioritize and meet deadlines in a timely manner.

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