The Regulatory Affairs Associate Director will be a strong regulatory partner to the Product Development and Business Teams. Will lead the organization in the development of submissions for product registrations, progress reports, supplements, amendments, and/or periodic experience reports, etc. Provides strategic product direction to teams and negotiates with regulatory agencies to expedite approval of IVD product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. May manage, lead and provide direction to Regulatory Staff and when required participate in Senior Management meetings as a delegate. Develops and drives a work culture committed to compliance, quality, and customer focus.
- Develop proactive approaches for regulatory activities to meet business requirements.
- Manages submission activities for a variety of device regulatory submissions and approvals including US premarket approvals (PMAs), US premarket notifications (510(k)s), IDEs, post-approval reports, annual reports, export certificates, and establishment registrations, device listings.
- May serve as a key member of the Regulatory Leadership team providing insights, solutions, and direction on general business and product portfolio matters.
- Provides regulatory support to new and currently marketed products, e.g., labeling, promotional material, product changes, and documentation for compliance and for changes requiring regulatory agency approval, as pertains to the US and international regulatory requirements.
- Review, interpret, and report to Regulatory leadership on product-specific regulatory issues that may have a material impact on the business or the customer.
- Work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Lead the identification of regulatory risk areas and develop alternative courses of action.
- Assess the impact of new regulations and work with the Organization to implement appropriate changes.
- Represent GRAIL during communications and meetings with Health Authorities and interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
- Ensure compliance with regulations and laws pertaining to the GRAIL business and provides guidance and advice.
- Independently review and approve Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and filingsManages the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- Provides regulatory support on the project team and serves as a functional lead on project teams.
- Provides consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues if required, responsible for managing indirect and direct reports which include, but is not limited to, hiring/firing decisions, selection, performance feedback, discipline, pay decisions, and handling employee’s grievances/complaints.
- Performs other duties as required or assigned