Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
About the role
- Associate Director for Global Regulatory Affairs in diagnostics at Johnson & Johnson. Supporting in vitro diagnostics regulatory strategy and submissions for therapeutic product development.
Responsibilities
- Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to the therapeutic product development.
- Oversee the coordination and compilation of global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs).
- Maintain appropriate external contacts and negotiate with HAs (U.S., EU, PMDA, and others) to obtain timely registration of the diagnostic products.
- Provide guidance, support, and educational training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy.
- Draft and/or review the U.S. and EU Study Risk Determinations for the investigational diagnostic products used in the therapeutic product clinical studies.
- In partnership with the diagnostic test provider, handle the timely coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities.
- Track Requests for Information (RFI) received from regulatory authorities related to diagnostic product submissions and manage the cross-functional responses to the RFI.
- Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic regulatory submissions.
- Participate in therapeutic product Global Regulatory Team (GRT) meetings and provide updates to the teams regarding diagnostic product deliverables and timelines.
- Participate in cross-functional diagnostic team meetings and meetings with the external diagnostic test providers to track and monitor deliverables.
- Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally.
- Monitor current and pending approvals in specific therapeutic/companion diagnostic/medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas.
- Provide assessments of the impacts of new and changing regulations on the company objectives to project and management teams.
- Support GRA Diagnostics in becoming a first-in-class organization by working internally and externally (i.e., participating in working groups, consortia, and trade associations, such as AdvaMed) to shape regulatory framework, identify process improvements.
Requirements
- A minimum of a Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or a health-related discipline is required.
- Advanced degree (Master’s, PharmD, PhD) preferred.
- A minimum of 10 years of experience in a decision-making role on a pharmaceutical therapeutic team is required.
- A minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510k, PMA) and EU CE Conformity Certification marking is required.
- A minimum of 5 years of translational science experience working with diagnostic test providers is required.
- Strong experience with regulatory submissions and communication with Health Authorities is required.
- Strong understanding of medical device development is required.
- Proficient understanding of in vitro diagnostic technologies is required.
- Knowledge of the drug development process is preferred.
- Knowledge of therapeutic product regulations is preferred.
- Regulatory Affairs Certification (RAC) is preferred.
- Experience successfully working within a cross-functional team environment as a contributor, decision maker, and creator of innovative regulatory strategies is required.
- Must have excellent verbal and written communication skills.
- Must have strong analytical and strategic thinking skills.
- Must be flexible and innovative with the ability to work in a changing, complex, and ambiguous environment.
- Must have the ability to work independently, managing daily activities and project deliverables with limited management oversight.
- The ability to present complex information to cross-functional project teams and senior management in a clear and concise manner is required.
- The ability to identify regulatory risks and mitigations is required.
- The ability to collaborate with all levels across a matrix organization is required.
Benefits
- Medical
- Dental
- Vision
- Life insurance
- Short- and long-term disability
- Business accident insurance
- Group legal insurance
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave - 10 days
- Volunteer Leave - 4 days
- Military Spouse Time-Off - 80 hours
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