Extensive knowledge of US and global medical device regulations
Strong leadership and team-building skills
Effective communication across multiple organizational levels
Ability to thrive in a fast-paced, dynamic environment
Responsibilities
Lead project submissions for regulatory approvals and proactively resolve issues
Apply regulatory expertise to support cross-functional partners
Develop global regulatory strategies for medical devices
Prepare regulatory applications to meet organizational objectives
Review and approve engineering changes
Provide training and guidance to regulatory and development teams
Ensure compliance of device labeling and marketing materials
Drive regulatory cross-functional alignment and strategic partnerships
Benefits
Flexible working hours
Opportunities for professional development
Collaborative team environment
Health and wellness programs
Supportive company culture promoting work-life balance
Full Job Description
Responsibilities:
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 of 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
Support 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
Multi-tasks, prioritizes and meets deadlines in timely manner
