Senior Regulatory Project Manager

Senior Regulatory Project Manager

The Senior Regulatory Project Manager is responsible for regulatory strategy development and execution of Companion Diagnostics (CDx) and IVD products. The Senior Regulatory Project Manager will provide oversight and lead all RA activities including global submission work in support of business priorities which could include, but not limited to, IDEs, EU IVDR TF, US 510k, US PMA, and will mentor the organization in these key areas. This role ensures smooth global commercialization and compliance, driving innovation and excellence in close collaboration with Biopharma partners. Furthermore, the Senior Regulatory Project Manager is responsible for reviewing policies, guidance documents and procedures; applying best practices; and collaborating with cross-functional teams (e.g., R&D, Quality, Clinical Operations, etc.) within the business units to support the total product lifecycle.

Job Responsibilities :

Responsibilities include but are not limited to the following :

• Lead regulatory strategy and execution in collaboration with external partnerships and product lifecycle management, ensuring compliance with global requirements applicable standards
• Maintain regulatory intelligence and execute regulatory plans, and ensure internal procedures are updated to reflect evolving US and international regulations in the CDx and IVD space
• Assess the impacts of relevant drug and diagnostic regulations on the 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, and provide inputs and updates to, business and clinical goals
• Provide device-specific regulatory insight / guidance during CDx / Pharma partner cross-functional meetings
• Provides audit support as needed.
• Leads implementation of department procedures and maintaining regulatory requirements.
• Responsibilities will entail problem solving complex issues and independent collaboration on complex project results, data analysis, and ownership of task execution and completion.
• Provides support RA and business leadership and performs other related duties and assignments as required.

Education and Experience :

Bachelor's, Master's, or higher degrees in a scientific or engineering discipline.

Demonstrated success of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices.

Extensive experience working with cross functional teams developing companion diagnostics and devices. Substantial 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 with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to the regulatory and business leadership team and other governing bodies required

Demonstrated success of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.

RAC Certification is a plus.

Good understanding of drug development is a plus.

Flow cytometry experience is a plus.

CDx experience is required.

Knowledge and Skills :

Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.

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 because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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 or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.