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Senior Regulatory Affairs Specialist

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Zimmer Biomet

Aug 5

Applications are closed

  • Job
    Full-time
    Senior (5-8 years)
  • Galway

Requirements

  • Minimum of five years’ experience in medical device regulatory affairs
  • Experience with US Class III medical devices (PMA) preferred
  • Strong computer skills
  • Strong knowledge of EU and US medical device regulations
  • Submissions types to the U.S. FDA and EU Notified Bodies
  • Experience with in assessing medical device changes
  • Ability to stay abreast of regulations pertinent to medical devices
  • Ability to identify and assess business risks for a given regulatory strategy
  • Bachelor’s Degree (4-year university degree) life sciences, technical (engineering), quality or related field required with advanced degree preferred
  • Education in Medical Device Regulatory Affairs is a plus
  • A combination of education and experience may be considered
  • Demonstrated technical writing and communication skills
  • Strong attention to details
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
  • Ability to function well as a member of the team and build relationships between regulatory affairs and other areas of the organization

Responsibilities

  • Maintain Zimmer Biomet regulatory approvals and ensure compliance with all applicable regulations
  • Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notified Bodies and other worldwide government agencies as required to ensure timely approval for market release
  • Able to write regulatory justifications to support submission filing decisions
  • Prepare FDA regulatory submissions including US Class III 30 Day Notices and US Class II 510(k) submissions as applicable for product changes/Transfers
  • Prepare Change Notifications and submissions to EU Notified Bodies for Zimmer Biomet products
  • Prepare dossiers for registration of products in countries outside the U.S and EU
  • Support value improvement engineering teams on possible regulatory impact of proposed changes during project initiation and implementation
  • Apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization
  • Work with international Zimmer Biomet regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies
  • Provide support, training and guidance to junior RA team members
  • Establish and maintain regulatory information systems both electronically and hard copy

FAQs

What is the primary responsibility of a Senior Regulatory Affairs Specialist at Zimmer Biomet?

The primary responsibility is to develop and execute regulatory strategies to support tasks assigned to the Global Knee Manufacturing Regulatory Affairs team, including providing advice on regulatory requirements, preparing submissions, and maintaining regulatory licenses.

How many years of experience is required for the Senior Regulatory Affairs Specialist position?

A minimum of five years’ experience in medical device regulatory affairs is required.

Is experience with US Class III medical devices preferred for this role?

Yes, experience with US Class III medical devices (PMA) is preferred.

What kind of education is required for this position?

A Bachelor’s Degree in life sciences, technical (engineering), quality, or a related field is required, with an advanced degree preferred. Education in Medical Device Regulatory Affairs is considered a plus.

What types of regulatory submissions will I be preparing in this role?

You will prepare FDA regulatory submissions including US Class III 30 Day Notices and Class II 510(k) submissions, as well as Change Notifications and submissions to EU Notified Bodies.

Will I be responsible for training junior team members?

Yes, you will provide support, training, and guidance to junior regulatory affairs team members.

What personal skills are important for this role?

Demonstrated technical writing and communication skills, strong attention to detail, the ability to multitask, and the ability to build relationships within the organization are important for this role.

How does Zimmer Biomet approach employee development?

Zimmer Biomet focuses on development opportunities, robust employee resource groups (ERGs), and a culture of recognition and performance awards to support employee development.

Is knowledge of EU medical device regulations necessary for this position?

Yes, having strong knowledge of EU medical device regulations is important, including submissions types to EU Notified Bodies.

What is the company culture like at Zimmer Biomet?

Zimmer Biomet commits to creating an inclusive environment where every team member feels respected, empowered, and recognized.

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Zimmer Biomet

Moving You Forward.

Manufacturing & Electronics
Industry
10,001+
Employees
1927
Founded Year

Mission & Purpose

Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We advance our mission to alleviate pain and improve the quality of life for patients around the world with our innovative products and suite of integrated digital and robotic technologies leverage data, data analytics and artificial intelligence. Founded in 1927 and based in Warsaw, Zimmer Biomet has operations in more than 25 countries and sales in more than 100 countries. We maintain world-class scientific facilities and resources and collaborate with leading clinicians and researchers around the world.