Manager, Regulatory Affairs/Quality Affairs Software Applications

Danaher Portland , ME 04101

Posted 2 months ago

This position consists of three primary functions:

Managing department projects with strong focus on software applications to support, grow and improve departmental processes. Managing Danaher global software implementation projects. Providing compliance and process improvement support through project management, training, creating standard work, kaizens and workshop facilitation and support for enterprise, platform, OpCo and department support; with a focus on Cybersecurity and Data Protection.

Support of Danaher's Corporate Internal Audit team and MedTech Management Representatives to ensure the internal audit process aligns with company policies and procedures, as well as, external standards and regulations, including 21 CFR, ISO 13485, Medical Device Regulation (MDR), Canadian Medical Device Regulations (SOR), China Food and Drug Admin. (CFDA), In Vitro Medical Device Regulation (IVDR), Medical Device Single Audit Program (MDSAP), Marketing, Advertising, Promotion, Sales and Service (MAPSS) and other applicable standards and regulations.

Manage department projects with a primary focus on department software applications and databases to increase the scope, efficiency, and efficacy of the internal department processes. The scope of project management includes implementing, maintaining and improving software applications and databases in support of key department functions including auditing, reporting, training, document control, and department website.

Additional responsibilities include the facilitation of discussions with business process owners to capture and analyze business and technical process needs to formulate and develop new and modified business processes using software and DBS tools. Execution of various improvement initiatives in support of regulatory compliance and achieving strategic priorities and policy deployment objectives.

Essential Duties and Responsibilities

In addition to those identified below, other duties may be assigned.

Driving technology innovation and growth- responsible to drive efficiency improvements using software tools currently in use; or the implementation of new tools to provide efficiency gains and meet the strategic plan for future growth including the development of standard work. Project Management- serve as project manager, co-lead, and core team member.

Lead teams to achieve goals and meet success criteria, including completed deliverables, the use of DBS tools, defined timeline goals and budget goals. Scope includes department projects and pan Danaher projects. Cybersecurity- ensure data integrity of all departmental information in accordance with Cybersecurity regulations and Danaher policy.

Active member of the Danaher Global Product Security Sharing Council; execute and support activities and deliverables. Data Protection- ensure data integrity of all departmental information is in accordance with the DPP policy. Serve as QARA and EHS representative for DPP projects and initiatives.

Support ongoing pan Danaher software projects- e.g SuperAdmin level external standards. Sharepoint Admin- responsible for user rights, folder, and content management of the department sites. MasterControl Sysadmin- responsible for the configuration of MasterControl, assigning user rights, yearly upgrade validation and implementation, implementation and validation of new functionality/process improvements, training users on the use of the tool, working with the MasterControl team to resolve user/tool issues and ensuring the tool is used as designed. Responsible for driving increased use of the tool to obtain increased efficiency, record control and data collection.


  • Project management skills including software implementation, software feature enhancements including planning, budgeting, validation, stakeholders, time and prioritization management, indirect team management (internal and external).

  • Proficiency with the following software applications: Microsoft Office including Excel, Access, PowerPoint, Teams, MasterControl, website software, and learning management software.

  • Must be reliable and capable of working with minimal supervision to manage project planning, execution, and follow-up activities.

  • Ability to provide training via electronic software tools, classes, web sessions, presentations, and written instructions.

  • Ability to communicate via, remote sessions as well as presenting for large groups.

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

  • Analytic skills including data gathering, interpretation and communication. Applying data patterns towards effective decision making and process improvements.

  • The ability to create, share and exchange information in virtual communities and networks.

  • Computer Science skills including problem solving, programming, and planning.

Education and/or Experience

Bachelor's degree (B.A. or B.S.) in a science discipline from a four-year college or university; and a minimum four years related experience and/or training; or equivalent combination of education and experience.

Language Skills

English fluency required. Additional language skills are beneficial.


Approximately 20%-40% travel (domestic and international)

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

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Manager, Regulatory Affairs/Quality Affairs Software Applications