This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates 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.
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Provides Regulatory leadership to development teams:
- Provides global strategic input (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.
- Assists with audits and inspections, if required.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Minimum 10 years experience in US/EU regulatory submissions for Class 3 PMA products with success in FDA/EU product submission and approvals
- Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions