Sr. Manager/Director of Regulatory
The Sr. Manager/Director of Regulatory Affairs is responsible for overall management and direction of Regulatory Affairs and other departments as assigned to assure achievement of business objectives and government compliance. Proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure. Plans, manages and coordinates complex global regulatory strategies and submissions to ensure that regulatory objectives are met. In addition, she or he is responsible for 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 directs implementation and activities to achieve goals.
- Prepares annual Regulatory department budget in coordination with Finance department.
- Directs regulatory strategy development for government submissions and incorporates into product development plans.
- Plans, coordinates, and executes regulatory submissions as appropriate and has 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.
- Participates on project teams as primary Regulatory Affairs Representative providing appropriate information on regulatory issues and obtaining needed information to meet regulatory requirements.
- Reviews all labeling for compliance with regulations and ensures that claims are substantiated and sustained.
- Serve as regulatory liaison with designated regulatory bodies on behalf of ReShape Lifesciences to facilitate timely and favorable review of submissions and issues.
- Maintains current knowledge base on existing and emerging regulations, standards, and guidance documents.
- Reviews 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.
- Reviews document change requests and completes assessments for worldwide regulatory impact.
- Reviews complaint reports to determine, complete, and communicate required reporting in accordance with international regulations (e.g., US MDR, EU vigilance, Canadian MPR, etc.)
- Provides regulatory support and guidance to audits by regulatory bodies.
- Ensures organizational compliance with FDA regulations pertaining to regulatory submissions.
- Ensures organizational compliance with 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.
- Develops department Standard Operating Procedures (SOPs) and appropriate corporate Quality System procedures as required.
- Provides Regulatory training as applicable to the ReShape Lifesciences team.
- Manage use of regulatory consultants or contractors as needed to help facilitate timely and favorable review of submissions and issues.
- Works with Research to achieve and maintain Good Laboratory Practice compliance as required.
- Works with Clinical to achieve and maintain Good Clinical Practice compliance as required.
- Works with Quality organization to achieve and maintain FDA Quality System Regulation compliance and compliance with ISO requirements.
- Works with cross functional organizations to identify, achieve and maintain compliance with applicable international standards.
- As the company grows, providing personnel management for regulatory staff with responsibilities for staffing, work direction, mentoring, and evaluation.
- BA/BS technical field or scientific discipline (biology, engineering, physical science, etc.)
- 10+ years of experience in US regulatory medical device submission experience preparing IDE and PMA submissions
- 10+ years of experience in the medical device industry
- 10+ years of experience developing, interpreting or applying standards, guidelines and special controls
- 5+ years of project management and experience with international submission preparation experience including the EU, Australia and Mexico
- Experience with active implantable medical devices
- Strong working knowledge and application of FDA regulations and requirements with the ability to integrate into projects
- Strong US PMA supplement and reporting experience
- Strong Active Implantable device and associated design dossier experience
- Regulatory experience must include strategy development, submission authoring and publication
- Significant advertising/promotion review experience
- Working knowledge and experience with adverse event reporting; especially 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
- Significant experience in review and interpretation of international standards
- Self-motivated with outstanding prioritization skills
- Demonstrated strong interpersonal, communication, negotiation and project management skills
- Strong oral and written skills to effectively communicate technical information and keep executive management informed
- Regulatory Affairs Certification by Regulatory Affairs Professional Society a plus
- Standing, sitting, walking, climbing stairs, light lifting, computer operation