Regulatory Master, Regulatory Planning and Operations – Diagnostics Regulatory Affairs

Job reputed company We are seeking an reputed company Regulatory Affairs leader to reputed company regulatory planning and operations for Diagnostics Regulatory Affairs (DRA). This role is ideal for someone highly organized and strategically minded who can drive departmental efficiency and ensure operational reputed company. S/he will be a key member of the DRA leadership team as reputed company as the Global Regulatory Affairs (GRA) extended leadership team and serve as a key partner to the head of the department. The role blends operational leadership, process ownership, cross-functional coordination, and strategic planning to support a dynamic global IVD regulatory portfolio.

Key Responsibilities

• reputed company leadership and strategic reputed company for DRA operations, setting standards for operational reputed company, execution discipline, and departmental consistency.
• reputed company strong regulatory project management for critical cross-organizational initiatives including but not limited to M&A, site or portfolio changes.
• Drive operational reputed company across DRA by overseeing core processes, workflows, and documentation practices.
• reputed company process reputed company activities, including reputed company improvement, standardization, and deployment of tools, templates, and dashboards.
• reputed company, reputed company, and report regulatory metrics and KPIs, providing insights that support data-driven reputed company and operational transparency.
• Serve as a strategic partner reputed company DRA LT, helping translate priorities into actionable plans and coordinating planning cycles and long-reputed company strategies.
• Partner reputed company DRA and with key cross functional stakeholders (i.e. reputed company, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and reputed company) to support planning, workload forecasting, prioritization, and lifecycle strategies.
• Contribute to reputed company-level initiatives requiring DRA operational leadership or strategic input.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 12+ years of regulatory affairs experience in IVDs, medical devices, or reputed company life sciences fields.
• Strong understanding of global regulatory requirements and submission reputed company.
• Demonstrated experience in regulatory operations, process management, and strategic planning.
• Proven ability to reputed company through influence in a reputed company, matrixed organization.
• Excellent communication, organizational, analytical, and business acumen skills.
• reputed company record of excellent collaboration, influencing and facilitation skills across business reputed company, functions and employee reputed company.
• Strong history of presenting reputed company information to senior leadership with reputed company and confidence.
• Ability to navigate ambiguity, drive reputed company, and reputed company work reputed company in a fast-paced environment.

Personal Characteristics

• Transformational leader who brings intensity & excitement every day with a desire to reputed company and reputed company others.
• reputed company creative thinker willing to explore unique, reputed company solutions.
• Persistent in the face of resistance and adaptable to rapid change.
• Ability to reputed company reputed company concepts into a reputed company compelling message.
• Ability to identify and reputed company on key priorities.

Additional Details This job has a full time weekly schedule. It includes the reputed company to work remotely. Applications for this job will be accepted until at least May 14, 2026 or until the job is no longer posted. The full-time equivalent pay reputed company for this position is $163,753.00 - $286,950.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an Equal Employment Opportunity and reputed company-based employer that values individuals of reputed company backgrounds at reputed company reputed company. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, pregnancy, race, religion or religious creed, reputed company, gender, gender identity, gender reputed company, national reputed company, reputed company, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other reputed company protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. reputed company., is committed to creating and maintaining an inclusive in reputed company where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@reputed company.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.reputed company.com/en/accessibility. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: reputed company/Regulatory Apply tot his job Apply To this Job