Regulatory Affairs Manager

What You Can Expect

As a Project Manager you will be responsible for leading the planning, governance and delivery of projects within the Regulatory Affairs PMO organisation. The role coordinates cross-functional and international stakeholders, translates strategic objectives into executable project plans, and drives delivery against agreed scope, timelines, resources, risks and quality expectations. The Project Manager provides transparent communication to sponsors and leadership, maintains robust project controls, and promotes consistent PMO ways of working across the organisation. This permanent position is based in Warsaw, Indiana US and follows a hybrid working model with regular on-site presence. The role reports to the PMO RA Organisation Leader.

How You'll Create Impact

• You will lead the planning and governance of Z10 projects within the Regulatory Affairs PMO, including project charters, scope, objectives, milestones, deliverables, assumptions, dependencies and success measures.
• You will manage end-to-end project execution by coordinating cross-functional and international teams, maintaining integrated schedules, tracking actions and ensuring agreed deliverables are completed on time and to the required quality.
• You will establish clear and consistent project communication, including team meetings, steering updates, status reports, decision logs and escalation of matters requiring leadership attention.
• You will identify, assess and manage project risks, issues, changes and interdependencies; develop mitigation and recovery plans and maintain appropriate project controls and records.
• You will support resource and financial planning, monitor project effort and costs where applicable, and prepare business cases or funding requests in collaboration with sponsors and finance partners.
• You will drive continuous improvement of PMO ways of working, templates, reporting and collaboration tools; facilitate workshops and ensure actions are tracked through to closure.

What Makes You Stand Out

• You have strong planning, prioritisation and organisational skills, with the ability to manage multiple workstreams, dependencies and competing deadlines.
• You have demonstrated ability to lead complex, cross-functional projects in a matrix organisation, using influence, structure and sound judgement to achieve results.
• You have the ability to identify risks and issues early, make pragmatic decisions, develop mitigation plans and escalate matters appropriately.
• You are collaborative, inclusive and relationship-oriented approach; able to build trust and maintain commitment across functions, geographies and levels of the organisation.
• You have a continuous-improvement mindset, with interest in simplifying processes, improving reporting and using collaboration tools effectively.
• You are proficient in Microsoft Office applications; experience with project planning, reporting and collaboration tools such as Microsoft Project, SharePoint or equivalent.

Your Background

• You have a Bachelor’s degree in business, life sciences, engineering, healthcare, regulatory affairs or a related discipline required; advanced degree is an advantage.
• You have a minimum of 5 years of project or programme management experience, preferably in a regulated medical device, pharmaceutical, healthcare or other life sciences environment.
• You have experience managing projects in a global or international matrix organisation and working with senior stakeholders.
• You have experience in Regulatory Affairs, quality, compliance, product development or another regulated function.
• You have project management certification such as PMP, PRINCE2 or equivalent.

Travel Expectations

• Primary work location: Warsaw, Indiana US.
• Hybrid working model with regular on-site attendance and flexibility to attend in-person project meetings, workshops and stakeholder sessions as required.
• Occasional travel may be required in support of project delivery and collaboration with other Zimmer Biomet locations.
• Expected compensation for the role is $113,000 - 141,000 base pay plus performance bonus.