Director of Regulatory, Clinical Affairs and Product Labeling
Business Unit: Strategy & Innovation
Requisition Number: 231031
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 30%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Director of Regulatory, Clinical Affairs and Product Labeling will manage a team of 15+ professionals responsible for devising regulatory and clinical trial strategies and delivering product labeling for Molecular In-Vitro Diagnostics products using PCR technology. The Director will define the requirements for a wide range of assays and drive the regulatory planning, execution and validation strategies, and he/she will collaborate with other teams internationally to successfully deliver multiple submissions in the United States, the EU, and Rest of the World. The Director will be responsible for guiding and supporting Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on regulatory, clinical, and product labeling topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
The Director will also guide and participate in new product development teams, while ensuring compliance with all applicable domestic and international standards and regulations and maintenance on the market; interpreting regulations and guidelines and preparing and executing plans. In addition, the Director will serve as a scientific and clinical liaison between internal teams and external groups such as CROs, regulatory authorities, professional and public health organizations, key opinion leaders, and advisory boards. He/she will be responsible for devising the medical strategy for new products and their potential medical value, while defining potential clinical utility for company products. This position will be responsible for managing the Product Labeling team, which is responsible for content development for product documentation, end-user instructions, operator’s manuals, and other labeling or documentation for Molecular Diagnostics products. The position provides senior leadership internationally and across functions and reports to the VP of Quality and Operations, located in Berkeley, California.
Education and Experience
• An M.S. or Ph.D , preferably in areas of microbiology, virology, or immunology and/or deep understanding of molecular and virology laboratory techniques
• 10+ years of experience in clinical trial research and regulatory submissions (PMA and 510k), supporting new product launches as well as product updates in the IVD or Molecular Diagnostics field.
• Professional designations are not required, but training and certificates in quality, clinical affairs, or regulatory affairs is a plus (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
• 5+ years of management experience, with proven track record of delivering projects on time and promoting high performance behaviors within a team
• Experience in interfacing with key opinion leaders including physicians and clinical laboratorians
• Prior experience working with cross-functional project teams, IRBs and external business partners
• Proven track record launching new products globally following design controls required
• Demonstrated ability to design studies, and write and review the resulting study reports and publications
• Prior medical device writing experience, medical package insert experience, complex hardware operation and service procedure experience or scientific writing experience preferred.
Required Knowledge and Skills
• Understanding of regulations and guidelines governing the areas of medical device and in-vitro diagnostic development, with a broad knowledge of requirements and best practices in Clinical Affairs, Regulatory Affairs and Product Development
• Ability to assist Research and Development Groups with assay design and design verification and validation
• Excellent verbal and written communication skills; ability to communicate issues in a simple way and to orchestrate plans to resolve issues and risks.
• Excellent interpersonal skills and ability to develop relationships with key stakeholders, including Clinical, Regulatory, Product Labeling Quality, Research, Development, and Marketing groups
• Agile and flexible team player with the ability to meet project timelines, complete deliverables, and build and foster global relationships to meet all regulatory and clinical requirements
• Analytical skills to digest and quickly grasp large amounts of data and to recognize key issues and ideas
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient with proven ability to manage multiple time-sensitive high priority projects
• Critical-thinker with excellent negotiation skills and the ability to address complex situations independently, and the ability to adopt a systemic view of continuous process improvement to support business goals and decisions
• Ability to develop or revise procedures and processes
Willingness to travel up to 30%