BD (Tissuemed Ltd)
Sr. Manager, Regulatory Affairs, CDx
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Overview
Sr. Manager, Regulatory Affairs, CDx at BD (Tissuemed Ltd). We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our medtech products—to look at the impossible and find transformative solutions. Job Description Summary
The Senior Regulatory Project Manager is responsible for regulatory strategy development and execution of Companion Diagnostics (CDx) and IVD products. This role provides oversight and leads all RA activities, including global submission work in support of business priorities (e.g., IDEs, EU IVDR TF, US 510(k), US PMA). The role will mentor the organization in these areas and works to ensure smooth global commercialization and compliance, collaborating with Biopharma partners. The Senior Regulatory Project Manager reviews policies, guidance documents and procedures, applies best practices, and collaborates with cross-functional teams (e.g., R&D, Quality, Clinical Operations) within the business units to support the total product lifecycle.
Job Responsibilities
Lead regulatory strategy and execution in collaboration with external partnerships and product lifecycle management, ensuring compliance with global requirements and applicable standards Maintain regulatory intelligence and execute regulatory plans; ensure internal procedures reflect evolving US and international regulations in the CDx and IVD space Assess impacts of relevant drug and diagnostic regulations on development and registration activities for the respective medical products Develop and manage regulatory submissions (e.g., IDE, 510(k), PMA, EU Technical Dossier), including documentation, timelines, and agency interactions to secure product approvals Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with business and clinical goals Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings Provide audit support as needed Lead implementation of department procedures and maintain regulatory requirements Solve complex issues and independently manage project results, data analysis, and task execution Provide support to RA and business leadership and perform other related duties as required
Education And Experience
Bachelor’s, Master’s, or higher degree in a scientific or engineering discipline Demonstrated success with FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices Extensive experience with cross-functional teams developing companion diagnostics and devices; experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions Experience coordinating regulatory strategies with clinical plans and marketing objectives; ability to communicate strategy, issues, and risks to regulatory and business leadership Demonstrated success in Global Regulatory Strategy within Drug and Device Development and Commercialization RAC Certification is a plus Understanding of drug development is a plus Flow cytometry experience is a plus CDx experience is required
Knowledge And Skills
Understanding of Global Regulatory Strategy in Drug and Device Development and Commercialization RAC Certification is a plus Flow cytometry experience is a plus
Physical Demands
None – desk work
Work Environment
Hybrid
At BD, we prioritize on-site collaboration to foster creativity and problem-solving in a fast-paced healthcare environment. Some roles require in-office presence; remote or field-based arrangements will be indicated in the job posting. BD may require proof of COVID-19 vaccination where permitted by law, with accommodations pursuant to applicable law.
Why Join Us?
BD offers a culture that values your opinions and contributions, supports learning and growth, and emphasizes doing what’s right and holding each other accountable. We invite you to help reinvent the future of health.
For more information, visit our careers site. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, disability, military status, or other legally-protected characteristics.
Salary Range Information
Salary Range:
$155,900.00 - $257,300.00 USD Annual
#J-18808-Ljbffr
Sr. Manager, Regulatory Affairs, CDx at BD (Tissuemed Ltd). We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our medtech products—to look at the impossible and find transformative solutions. Job Description Summary
The Senior Regulatory Project Manager is responsible for regulatory strategy development and execution of Companion Diagnostics (CDx) and IVD products. This role provides oversight and leads all RA activities, including global submission work in support of business priorities (e.g., IDEs, EU IVDR TF, US 510(k), US PMA). The role will mentor the organization in these areas and works to ensure smooth global commercialization and compliance, collaborating with Biopharma partners. The Senior Regulatory Project Manager reviews policies, guidance documents and procedures, applies best practices, and collaborates with cross-functional teams (e.g., R&D, Quality, Clinical Operations) within the business units to support the total product lifecycle.
Job Responsibilities
Lead regulatory strategy and execution in collaboration with external partnerships and product lifecycle management, ensuring compliance with global requirements and applicable standards Maintain regulatory intelligence and execute regulatory plans; ensure internal procedures reflect evolving US and international regulations in the CDx and IVD space Assess impacts of relevant drug and diagnostic regulations on development and registration activities for the respective medical products Develop and manage regulatory submissions (e.g., IDE, 510(k), PMA, EU Technical Dossier), including documentation, timelines, and agency interactions to secure product approvals Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with business and clinical goals Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings Provide audit support as needed Lead implementation of department procedures and maintain regulatory requirements Solve complex issues and independently manage project results, data analysis, and task execution Provide support to RA and business leadership and perform other related duties as required
Education And Experience
Bachelor’s, Master’s, or higher degree in a scientific or engineering discipline Demonstrated success with FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices Extensive experience with cross-functional teams developing companion diagnostics and devices; experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions Experience coordinating regulatory strategies with clinical plans and marketing objectives; ability to communicate strategy, issues, and risks to regulatory and business leadership Demonstrated success in Global Regulatory Strategy within Drug and Device Development and Commercialization RAC Certification is a plus Understanding of drug development is a plus Flow cytometry experience is a plus CDx experience is required
Knowledge And Skills
Understanding of Global Regulatory Strategy in Drug and Device Development and Commercialization RAC Certification is a plus Flow cytometry experience is a plus
Physical Demands
None – desk work
Work Environment
Hybrid
At BD, we prioritize on-site collaboration to foster creativity and problem-solving in a fast-paced healthcare environment. Some roles require in-office presence; remote or field-based arrangements will be indicated in the job posting. BD may require proof of COVID-19 vaccination where permitted by law, with accommodations pursuant to applicable law.
Why Join Us?
BD offers a culture that values your opinions and contributions, supports learning and growth, and emphasizes doing what’s right and holding each other accountable. We invite you to help reinvent the future of health.
For more information, visit our careers site. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, disability, military status, or other legally-protected characteristics.
Salary Range Information
Salary Range:
$155,900.00 - $257,300.00 USD Annual
#J-18808-Ljbffr