Director of Regulatory Affairs
ReShape Lifesciences is looking for a Director of Regulatory Affairs to join our growing team.
In this role you would be responsible for proactively evaluating existing and emerging regulatory and quality requirements and direct implementation activities to minimize business exposure, as well as ensuring that ReShape Lifesciences activities are compliant with FDA, state and applicable OUS regulations.
ESSENTIAL JOB FUNCTIONS (including but not limited to):
- Participate in management meetings and provide regulatory strategy and guidance to meet company objectives in establishing business short- and long-range strategic business goals and direct implementation and activities to achieve goals.
- Direct regulatory strategy development for government submissions and incorporate into product development plans.
- Plan, coordinate and execute regulatory submissions as appropriate and have sign-off responsibility to obtain and sustain commercial approval.
- Project team leader for cross-functional teams as assigned. Responsible for informing management of project progress and establishing project timelines in accordance with department and corporate objectives.
- Review all labeling for compliance with regulations and ensure that claims are substantiated and sustained.
- Review new projects to determine the nature and scope of regulatory involvement; and independent responsibility for determining and providing written regulatory strategies for new product ideas.
- Review document change requests and complete assessments for worldwide regulatory impact.
- Review complaint reports to determine, complete and communicate required reporting in accordance with international regulations (e.g., US MDR, EU vigilance, Canadian MPR, etc.)
- Ensure organizational compliance with FDA regulations pertaining to regulatory submissions as well as international regulations, standards and requirements pertaining to regulatory submissions.
- Responsible for planning and executing meetings with or related to global regulatory authorities (eg, Notified Body, FDA and Advisory Panel meetings) as appropriate.
- Develop department Standard Operating Procedures (SOPs) and appropriate corporate Quality System procedures as required.
- BA/BS in technical field or scientific discipline (biology, engineering, physical science, etc.)
- US regulatory medical device submissions
- Strong background in IDE and PMA submissions
- Ability to develop and interpret applying standards, guidelines and special controls
- Project management and experience with international submission (i.e. Mexico)
- Strong working knowledge and application of FDA regulations and requirements
- Significant advertising/promotion review experience
- US MDR reporting decision, preparation, and submission experience
- Demonstrated effectiveness in managing and participating in regulatory body audits and inspections
- Strong quality systems knowledge, particularly requirements of US Quality System Regulation and ISO 13485