Subchapter Lead, Near Patient Care

Roche • Washington, DC

253d • $106,760 - $245,700 • Hybrid

About The Position

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. As a Near Patient Care Subchapter lead in the Medical Value Assays Chapter, you will be a member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT). In this position, you will be a leading figure and key point of contact for Roche Diagnostics' regulatory capabilities in Near Patient Care. You will improve the Subchapter's overarching expertise based on current and upcoming needs to deliver on network priorities (e.g. upcoming portfolio investments with new technology skills needed). You will be responsible to excel in developing the capabilities of Subchapter members, including their skills in technical regulatory knowledge, strategic thinking, verbal and written communication. As a people leader of Subchapter members, you will be responsible for designing and optimizing Subchapter members' personal professional journey and coaching your direct reports. Furthermore, you will have the responsibility to maintain and improve all processes, data and technology associated with the Subchapter.

Requirements

• Bachelor or Advanced degree in science or a related field.
• General understanding of the Diagnostics industry, lifecycle & development process and global trends.
• 7+ years of experience in Regulatory Affairs within diagnostics industry or a related field, ideally with expertise in Near Patient Care devices.
• Knowledge in IVD, Pharmaceutical, and/or Medical Device industry; Regulatory Compliance, Federal cGMP's and QSR's, ISO13485 and 27001.
• Experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China).
• Proven knowledge and thought leadership on aspects relevant subject matter of the subchapter.
• Strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication and stakeholder management.
• History of successful interactions with regulatory bodies.

Nice To Haves

• Experience defining career progression and development capabilities for Regulatory Affairs in networked organization.

Responsibilities

• Develop and coach 10-15 Regulatory Affairs staff to enable the greatest impact for our customers.
• Oversee the growth of technical regulatory capabilities.
• Manage knowledge and expertise within the team.
• Coach and empower staff to deliver best in class Regulatory processes, practices and submissions strategies leading to successful diagnostic solutions registrations.
• Serve as subject matter expert with the US FDA, Notified Bodies, international regulatory agencies and other regulatory bodies to advance project objectives.
• Monitor the global regulatory environments and provide staff and stakeholders with assessments of the impact of new and changing regulations.
• Manage resources effectively across the team, in alignment with the respective Lifecycle teams.
• Drive process standardization and reuse where it makes sense, balancing creativity and innovation.
• Foster an agile mindset and ways of working with a focus on delivering high quality submissions.
• Act as an active coach and mentor to members of the subchapter to help them grow and progress in their career.
• Nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter.
• Ensure that personal professional development is a priority in assignments of subchapter members.
• Enable the organization's New Ways of Working, including acting as a role model for Agile Leadership behaviors.
• Model behaviors to support the organization's transformation to new, more Agile Ways of Working.
• Commit to cross-functional collaboration and breaking down silos to achieve the best results for the organization.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Comprehensive health benefits.
• Opportunities for professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree