This company is a global leader in advanced molecular testing solutions. They are seeking a Regulatory Affairs Director who can lead global regulatory strategies for a portfolio of IVD products and manage a small team. You will provide regulatory guidance to internal teams, while also interfacing with global regulatory agencies. This company offers a competitive salary, comprehensive employee benefits, and a dynamic environment. Now is an exciting time to join this growing global organization!
- Provide guidance to internal departments on developing strategies, policies, and procedures that ensure regulatory compliance and submission success for IVD products with global regulatory agencies.
- Research and interpret global regulations, guidelines and precedents.
- Define and execute global regulatory and submission strategies.
- Partner with international leadership in conjunction with global business teams to plan, execute, and report on submissions.
- Identify issues that may increase regulatory risks and propose strategies to address such risk.
- Interface with regulatory agencies for pre-submissions, submissions, inquiries, and other issues.
- Lead teams and interface with other departments to deliver on regulatory strategies and submissions for both new development and new intended uses for existing products.
- Develop processes to accelerate approvals in the global markets.
- Develop and manage global regulatory strategies and activities for submission, registrations and maintenance for a portfolio of IVD products.
- Oversee the preparation and submission of 510(k)s and PMAs etc. to the appropriate regulatory agencies for assigned projects.
Knowledge and Skills:
- BS degree in a scientific field.
- At least eight years of regulatory affairs experience for diagnostics.
- Regulatory experience with In Vitro Diagnostics required.
- Experience leading and overseeing the preparation of US FDA 510(k) and/or PMA submissions for IVDs.
- Extensive knowledge of requirements and processes for US regulatory approval of in vitro diagnostic medical devices. Ex-US regulatory knowledge is a plus.
- Proven managerial experience of Regulatory Affairs across multiple countries in a remote management function.
- Demonstrated organizational, planning and prioritizing abilities are required, as well as strong technical writing ability.
- Demonstrated strong attention to detail; ability to work under pressure to meet deadlines.
- Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
- Flexibility to adjust to changes in schedule, priorities, product availability.
- Good verbal and written communication skills.