Regulatory Affairs Senior Specialist (709183)

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

This position effectively supports a defined process and adheres to all corporate and site specific procedures as applicable. This individual executes to the process with a focus on a defined steps of the process. This position is responsible for decision making of the defined steps of a process. Provides guidance and feedback to other team members pursuant to the defined procedures. . Responsible for follow up with division personnel, site team, and International team members to ensure effectiveness and responsiveness related to process. Responsible for communication of data related to the process to site and division leadership.

Principal Duties and Responsibilities

Adheres to all corporate and site specific procedures.
Identifies and investigates solutions to procedure and process related issues. Revises the procedure or process as needed to increase efficiency and compliance.
Documents and maintains records in accordance with corporate and site specific procedures.
Creates, maintains and monitors appropriate metrics to measure the key performance indicators of the unit.
Evaluates, assesses and executes the assigned steps within in the process.
Provides direction to internal and external personnel on issues related to the defined steps/process.
Assists Management in special projects as required.

Expected Areas of Competence

• Excellent organizational and time management skills
• Excellent written, oral, and presentation communication skills.
• Knowledge of EtQ, JD Edwards, Internet, Microsoft Office applications and the ability to learn other software quickly as required
• Detail-oriented
• Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simply analyses with accuracy
• Excellent decision making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive to critical situations, as this position has a high volume of work, regulatory-mandated time limits, and often changing priorities
• Action-oriented. Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
• Proven ability to work in a team setting. Willing to share the load and participate in projects outside of typical day-to-day job scope. Ability to work closely with others to assure functional commitments are met.
• Proven ability to provide training to Team Members as needed
Ability to work with all individuals in a congenial and cooperative manner

Education/Experience Requirements

• Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred or Bachelor’s degree in another discipline with equivalent years of relevant experience
• 5+ years’ experience required, preferably in the medical device industry
Alternatively, a Master’s degree in a related area with 3+ years’ of work experience will be accepted

Travel Requirements

Up to 5%

Additional Information

EOE M/F/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.