Sustaining & Compliance Projects Senior Manager, Regulatory Affairs

Sustaining & Compliance Projects Senior Manager, Regulatory Affairs

Job Summary:

The Sustaining & Compliance Projects Senior Manager will be responsible for ensuring continued regulatory compliance of the portfolio as worldwide regulations and standards, as well as internal policies, procedures, and business goals, evolve. The position will lead a team of regulatory project managers and be responsible for ensuring all projects remain on schedule and deliverables are met. The role will routinely work with cross functional teams and contractors to achieve goals. Critical thinking, strategic agility and dealing with ambiguity are key skill sets for this role.

Job Responsibilities:

(Primary Duties, Roles, and/or Authorities)

• Works closely with RA LT members to ensure alignment of regulatory strategies with business objectives.
• Provides leadership to a team of regulatory project managers as they run various sustaining and compliance projects.
• Stays abreast of worldwide regulations and standards and communicates potential risks and mitigation strategies to stakeholders.
• Possesses extensive knowledge of Quality Management System (QMS) and assesses impacts of compliance and sustaining projects.
• Assesses need for regulatory submission and oversees submissions w necessary.
• Represents Regulatory for all Field Safety Corrective Actions and Situation Analyses.
• Represents company interests in external activities benefiting Waters Advanced Diagnostics (ADx), including trade associations, professional organizations, and standards development organizations.
• Manages and develops regulatory affairs project managers and specialists carrying out compliance/sustaining activities. Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives. Aligns right capabilities to challenging tasks.
• Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
• Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.