Search by job, company or skills

Zimmer Biomet

Reg Affairs Distribution Controls

Save
new job description bg glownew job description bg glownew job description bg svg
  • Posted an hour ago
  • Be among the first 10 applicants
Early Applicant

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

The RA Systems Specialist is a member of the RA Distribution Control Team (previously RA Operations and RA Corporate) to support the RA distribution control activities globally. The resource will work closely with RA professionals from the Business Units (BU) and the regional teams. The RA Systems Specialist will provide guidance on the license types and the objective evidence needed to maintain specific licenses. The resource will also act as liaison with the Global Customer Operation (GCO), Regulatory Compliance, Supply Chain teams and other relevant departments based at the Global Supply Chain Center (GSCC).

Work Location: Bangalore

Work Mode: Hybrid (3 Days in office)

How You'll Create Impact

  • Support the Global RA distribution control activities
  • Provide trainings on RA processes and systems as needed
  • Act as SME for RA distribution control systems as needed, including Windchill, GTS, GUDID, etc.
  • Coordinate with the RA teams the best strategies to implement country specific requirements within the RA Distribution Control Systems (e.g. MDR transition or other government regulatory changes)
  • Maintain and ensure data integrity and completeness in RA distribution control systems
  • Provide feedback to Regional and BU RA teams as to objective evidence documentation
  • Work with RA Systems management to prioritize activities, support the business as per established procedures, and to provide feedback for process improvement
  • Accurately publish relevant Unique Device Identification (UDI) requirements in the appropriate systems
  • Work with other departments (e.g. supply chain and global customer operation) to improve the existing processes and develop new processes as needed
  • Support validations within RA Systems as needed
  • Support the external/internal/regulatory audits with focus on distribution control as needed

What Makes You Stand Out

  • 2 to 5 year of relevant experience in the medical device, pharmaceutical or biotech industries (a combination of higher education and less experience can be accepted)
  • Knowledge of ERP Systems, particularly SAP/SOP and S4Hana
  • 1 to 2 years Distribution Control experience preferred
  • Good knowledge of statistics and experience using statistical packages for analyzing datasets.
  • Technical expertise regarding data models and database design development.

Your Background

Education And Experience Requirements

  • Experience Range: 2+ Years.
  • A Bachelor's Degree or higher in life science or other quantitative fields.

Personal Skills And Competencies

  • High-level written and verbal communication skills
  • Problem-solving attitude
  • Ability to perform data analysis and/or investigation
  • Competence to make recommendations of improvement or change
  • Ability to communicate at a professional level with different stakeholders including senior leadership
  • Strong sense of ethics

Travel Expectations

Upto 10%

EOE/M/F/Vet/Disability

More Info

Job Type:
Industry:
Employment Type:

About Company

Job ID: 146081325

Similar Jobs

Early Applicant