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Regulatory Labeling Manager Jobs in Indiana (NOW HIRING)

Zimmer, Inc.

Regulatory Affairs Manager

Warsaw, IN · On-site

This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international ...

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How much do regulatory labeling manager jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for regulatory labeling manager in Indiana is $54.21, according to ZipRecruiter salary data. Most workers in this role earn between $40.05 and $63.37 per hour, depending on experience, location, and employer.

What does a Regulatory Labeling Manager do?

A Regulatory Labeling Manager oversees the development, review, and approval of product labels and packaging to ensure compliance with all relevant regulations and guidelines. They coordinate with various departments, such as regulatory affairs, legal, marketing, and product development, to ensure that all labeling information is accurate and aligns with local and international laws. Their responsibilities often include managing labeling submissions to regulatory authorities, monitoring regulatory changes, and updating labels accordingly to maintain compliance.

How does a Regulatory Labeling Manager typically collaborate with cross-functional teams during the product development process?

As a Regulatory Labeling Manager, you will regularly collaborate with cross-functional teams including regulatory affairs, medical, legal, marketing, and product development. Your role involves ensuring that product labels meet both regulatory requirements and company standards by gathering input from these teams and facilitating consensus on label content. You’ll often lead meetings to align stakeholders, review draft labeling, and coordinate responses to regulatory authority feedback, making strong communication and project management skills essential. This collaborative environment also provides opportunities to broaden your expertise and visibility within the company, supporting long-term career growth.

What are the key skills and qualifications needed to thrive as a Regulatory Labeling Manager, and why are they important?

To thrive as a Regulatory Labeling Manager, you need expertise in regulatory compliance, labeling requirements, and scientific documentation, often supported by a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and global labeling databases is typically required. Strong attention to detail, project management, and effective cross-functional communication skills set top performers apart in this role. These skills are crucial for ensuring accurate, compliant labeling that meets health authority standards and supports product success in global markets.

What is the difference between Regulatory Labeling Manager vs Regulatory Affairs Specialist?

AspectRegulatory Labeling ManagerRegulatory Affairs Specialist
CertificationsRegulatory Affairs Certification (RAC), FDA certificationsRAC, FDA certifications
Work EnvironmentLeading labeling projects, cross-functional teamsSupporting regulatory submissions, research
Employer & Industry UsagePharmaceuticals, medical devices, biotechPharmaceuticals, medical devices, biotech

The Regulatory Labeling Manager focuses on developing, reviewing, and maintaining product labeling to ensure compliance with regulations. In contrast, the Regulatory Affairs Specialist handles broader regulatory submissions and compliance tasks. Both roles require similar certifications and are common in the same industries, but the Labeling Manager has a more specialized focus on labeling strategies and documentation.

What are the most commonly searched types of Regulatory Labeling jobs in Indiana?

The most popular types of Regulatory Labeling jobs in Indiana are:

What are popular job titles related to Regulatory Labeling Manager jobs in Indiana?

For Regulatory Labeling Manager jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Regulatory Labeling Manager jobs in Indiana look for?

The top searched job categories for Regulatory Labeling Manager jobs in Indiana are:

What cities in Indiana are hiring for Regulatory Labeling Manager jobs?

Cities in Indiana with the most Regulatory Labeling Manager job openings:

Regulatory Labeling Manager jobs near you
Infographic showing various Regulatory Labeling Manager job openings in Indiana as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $112,753 per year, or $54.2 per hour.

Regulatory Affairs Manager

Zimmer, Inc.

Warsaw, IN • On-site

Full-time

Re-posted 14 days ago

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.


What You Can Expect

Responsible for managing support of regulatory affairs systems used to support the Zimmer Biomet RA teams. This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals.

How You'll Create Impact

Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions

Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates

Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research

Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products

Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products

Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status

Writes, manages, and approves the development of package inserts

Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations

Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization

Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them

Provides training and guidance to entry-level associates, interns, specialists, and project managers

Communicates with Regulatory/Governmental agencies

Responsibility for oversight and prioritization of departmental tasks and projects

Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development

Miscellaneous responsibilities as assigned

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out
  • Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports
  • Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail
  • Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities
  • Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace; strong product knowledge
  • Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as applicable
  • Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization
  • Ability to identify and asses business risks to develop Regulatory strategy
  • Mastery anatomic knowledge
  • Ability to handle increasing levels of responsibility
  • Ability to build and lead a strong RA team; ability to lead and influence others
  • Strong computer skills
  • Ability to negotiate with regulatory agencies, management, and other groups as necessary
  • Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable
  • Drive regulatory strategy and execution for new product introductions, ensuring timely market access and compliance throughout the product lifecycle.
  • Serve as the primary Regulatory Affairs liaison for IT-related initiatives, partnering closely with cross-functional teams to represent regulatory requirements and business needs.
  • Evaluate emerging technologies, including Artificial Intelligence (AI) applications, and provide regulatory input and guidance on their implementation.
  • Collaborate with Project Management Office (PMO) teams to ensure effective planning, prioritization, and execution of strategic initiatives.
  • Lead and develop a team of regulatory professionals, providing coaching, feedback, and performance management for a team of approximately six - seven direct reports.
  • Analyze and communicate regulatory metrics, trends, and performance indicators using data visualization tools such as Power BI.Prepare and deliver executive-level presentations and communications, including the development of PowerPoint presentations for leadership and cross-functional stakeholders.
Your Background
  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
  • Advanced degree strong preferred
  • 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU
  • A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred
  • Regulatory Affairs Certification (US or EU) preferred
  • Manage regulatory change initiatives, including the planning, coordination, and execution of regulatory submissions related to product, process, and system changes.
  • A combination of education, experience, leadership, strategy and RA influence may be considered
  • Support the implementation, enhancement, and governance of regulatory IT systems and digital solutions.
  • Lead the intersection of Regulatory Affairs and IT by serving as the key regulatory representative for technology-driven initiatives. This role blends regulatory management, technical oversight, and project leadership to drive system improvements, support digital transformation efforts, and ensure regulatory requirements are effectively translated into IT solutions and business processes.
  • PMO or project management experience preferred.
  • Familiarity with regulatory information management systems and digital transformation initiatives, IT tools for regulatory.
  • Proficiency with Power BI and Microsoft PowerPoint.Excellent communication, stakeholder management, and cross-functional leadership skills.
  • Proven people leadership experience managing direct reports.

COMPENSATION

Salary Range 113,407.00 - 141,759.00 USD/annual

Physical Requirements
Travel Expectations

Up to 20%

This is a fully remote position; however, occasional travel is required based on business needs.
While this is a remote position, strong preference will be given to candidates located in or near Warsaw, Indiana, USA for our office.

EOE/M/F/Vet/Disability

Employment Type: OTHER

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