This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The primary role of the Director, IVD Design Control and Project Management, for reagent and collection kits, is to oversee the scientific aspects of an assay development/validation project to meet regulatory guidelines.
Job Description
- Lead and manage the IVD design control team, providing direction, support, and mentorship.
- Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure all IVD design control activities comply with applicable regulations and standards including assay development and validation and kit production.
- Core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during internal and external audits and inspections by supplying necessary documentation and addressing findings related to design control and regulatory compliance.
- Ensure the IVD design control processes comply with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards.
- Establish and maintain IVD design control procedures, templates, and tools.
- Ensure robust ISO14971 risk management processes are integrated into the design and development phases and risk management is performed
- Oversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Plan and conduct design phase review meetings
- Lead IVD design control activities for new product development projects, ensuring timely and compliant progression through design phases.
- Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure cohesive and compliant product development.
- Monitor project timelines, budgets, and resource allocation to ensure projects are completed on time and within budget and oversee the project management team for assay development.
- Drive periodic improvement initiatives to enhance IVD design control processes, efficiency, and product quality.
- Implement lessons learned from post-market surveillance and product performance to improve IVD design control practices.
- Develop and deliver training programs on IVD design control requirements for internal teams.
- Promote a culture of quality and compliance within the organization through regular communication and training.
- Expected travel needs approximately 25%.
To be successful in this role, you will have:
- Minimum of 10 years of experience in design control within the medical device or clinical laboratory industry
- PhD in science related field preferred
- In-depth knowledge of FDA regulations, ISO 13485, ISO14971, IVDR, CLIA, and other relevant standards
- Experience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirements
- Strong project management skills with experience leading cross-functional teams
- Proven leadership experience with the ability to manage and mentor a team
- Strong interpersonal and communication skills, good laboratory and organizational skills, including the ability to work independently and efficiently.
- Ability to multitask, along with an orientation toward teamwork and leadership, and strong creative thinking and problem-solving skills.
