Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Job Title: Director of Regulatory
Job Location: Berkeley, CA
The Director of Regulatory and Clinical Affairs will manage a team of currently 4+ professionals (Regulatory and Biostats) responsible for devising regulatory and clinical trial strategies for Molecular In-Vitro Diagnostics products using PCR technology. The Director will define the requirements for a wide range of assays as well as systems and drive the regulatory planning, execution and verification & validation strategies. He/she will collaborate with other teams internationally to successfully deliver multiple submissions in the United States, the EU, and Rest of the World and will liaison closely with the Director of Clinical Affairs. This role has also the responsibility to provide Regulatory support for Molecular products that are currently in the Field and changes they may face due to Suppliers and Regulations.
The Director will be responsible for guiding and supporting Business Groups, Markets and enabling functions to make decisions that will enable them to be Regulatory compliant. This involves being a confident advisor on regulatory and clinical 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 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 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 regulatory strategy for new products. The position provides senior leadership internationally and across functions and reports to the Interim Head of Regulatory and Quality, 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, including instrumentation and software used for testing
- 10+ years of experience in regulatory submissions (PMA and 510k), supporting new product launches as well as product updates in the IVD or Molecular Diagnostics field
- Experience with clinical trials, particularly with CROs
- 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 hiring competent staff, promoting high performance behaviors within a dedicated Regulatory team while delivering projects on time
- Experience in interfacing with regulatory agencies and key opinion leaders including physicians and clinical laboratorians. Connections and a network within the FDA will be critical
- Prior experience working with cross-functional project teams, IRBs and external business partners
- Proven track record launching new products globally following Design Controls
- Demonstrated ability to design validation 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 Regulatory Affairs and Product Development
- Ability to assist Research and Development Groups with assay 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 Quality, Research, Development, Product Labeling 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%
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Job ID: 187486
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
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