Regulatory and Clinical Affairs Manager

We are currently seeking aManager Regulatory and Clinical Affairsto join our Acute Care business unit.Join us at the intersection of innovation science and patient care. As Manager Regulatory and Clinical Affairs you will play a pivotal role in shaping the regulatory and clinical strategies that enable products to reach markets globally and improvepatient outcomes.You will lead a high-performing team collaborate with cross-functional partners across the organization and influence decisions that drive business success while ensuring compliance and patient safety.Thisrole is Remote or Hybrid in Portage Michigan.

What you will do

• Provide leadership for Regulatory Affairs and Clinical Affairs activitiesestablishingstrategies processes goals and metrics that drive measurable improvement and support businessobjectives.
• Lead regulatory and clinical team members to deliver projects and activities withappropriate qualityand timeliness including oversight of priorities timelines deliverables execution and resource needs.
• Drive integrated approaches to regulatory strategy market access clinical evidence generation and the development review and oversight of regulatory and clinical deliverables for new and existing medical devices.
• Manage day-to-day regulatory and clinical processes ensuring issues are appropriately evaluated escalated resolved and communicated.
• Lead teams supporting regulatory submissions registrations renewals clinical projects and clinical evidence activities across the product lifecycle.
• Provide direction on the interrelationship between regulatory strategy and clinical evidence including recommendations and implementation plans for new or changing requirements and expectations.
• Collaborate with Quality Assurance R&D Service Global Supply Finance Sales Marketing and other partners to ensure corporate goals and strategies are met.
• Establish annual budgets and quarterly forecasts for the function and manage priorities and resources accordingly.
• Establish and improve standard processes systems and controls to ensure clear ownership effective management and continuous improvement of regulatory and clinical activities.
• Chair meetings needed to drive closure of regulatory and clinical issues and decisions.
• Manage and provide updates on regulatory and clinical metrics trends risks and performance.
• Represent regulatory and clinical processes during internal and external audits and inspections.
• Define targets KPIs and performanceobjectivesfor individuals within the function and manage direct reports to meet or exceed expectations.
• Recruit select and onboard top talent; coach and develop team members; address performance issues; andmaintaina high levelof team engagement.
• Participate in advocacy and other activities of an advanced technical tactical audit or strategic nature.

What you need

• Bachelors degree in science engineering life sciences biology biomedical engineering nursing ora relateddiscipline; advanced or masters degree preferred.
• Minimum of 8 years of relevantexperience includingregulatory affairs and/or clinical affairs experience in the medical device industry.
• Minimum of 2 years of management experience and/ordemonstratedhigh-performanceleading critical projects or teams.
• Demonstrated ability to apply regulatory and clinical knowledge to cross-functional and interdivisional projects.

Preferred

• Experience planning or conducting clinical studies including Investigational Device Exemption (IDE) and post-marketing clinical studies strongly preferred.
• Demonstrated ability to integrate regulatory strategy and clinical evidence needs to support product development submissions market access and lifecycle activities.
• Strong written verbal listening communicationteam building and stakeholder-management skills.
• Demonstrated ability to collaborate effectively with and lead cross-functional teams and external stakeholders.
• Demonstrated ability to prioritize and manage multiple project workloads.
• Demonstrated experience with trending analysis metrics and reporting.
• Demonstrated leadership decision-making process-improvement and change-management skills.
• Experience with recruiting onboarding coaching and people development.
• Ability toinfluence acrossthe organization and communicate recommendations to management and cross-functional stakeholders.