Regulatory Affairs Specialist (temporary)

What You Can Expect

This is a fixed term full time position tied to global projects (12 months contract).

As a Regulatory Affairs Specialist, you will support development projects from design to certification; support and ensure compliance with applicable standards and handle certifications and registration; provide compliance and regulations directions. You will be the interface between Zimmer and notify bodies and competent authorities for all product registrations, change notifications and testing.

This position requires an understanding of applicable standards and regulations used, as well as certification processes and registrations.

How You'll Create Impact

• Manage compliance to applicable standard processes for products including application and submission to accredited laboratories, reviews of requirements and implementation.
• Manage recognized certification marks processes for products including dossier preparation, submission to accredited agencies, reviews of application and implementation.
• Manage the registration process worldwide.
• Conduct periodic regulatory/standards survey.
• Understand the regulatory direction of development project teams.
• Understand regulatory strategy for new products.
• Review proposed product changes for impact on regulatory status of the product.
• Interpret and apply EU MDR, Machinery, REACH, RoHS EU directives and FDA regulations to business practices and provide regulatory input, advice, and guidance to the organization.
• Manage change notification to notify body processes, countries representatives, including authoring and publishing electronic submissions.
• Maintain the CE technical documentation updated in accordance with products specification creation and changes.
• Provide support by preparing and providing documentation related to compliance of substances used for product specifications and manufacturing aids.
• Support Health Hazard Evaluation, products hold and sales block (distribution control) activities.

What Makes You Stand Out

• Demonstrate strong writing and communication skills.
• Strong attention to details, and ability to multitask.
• Understand the overall business environment, the orthopedic industry and the marketplace.
• Mastery of relevant regulations, ability to stay abreast of regulations pertinent to medical devices.
• Ability to function well as a member of the team and build relationships between QA/RA and other areas of the organization.
• Able to identify and assess business risks for a given regulatory strategy.
• Ability to diplomatically discuss sensitive information with consultants, suppliers, or customers.
• Motivation and commitment to results.
• Ability to apply Good Manufacturing Practices.
• Present and discuss clinical, design, manufacturing, etc. issues with internal and external personnel (distributors, vendors, inspectors, auditors, sales associates, etc.).
• Strong computer skills.

Your Background

You hold a Bachelor's degree (or equivalent) in life sciences, technical (engineering) or related field. In addition a Regulatory Affairs Certification (US and/or EU) is preferred.

You have at least 2 years of experience in regulatory affairs with a strong knowledge of medical devices regulations, ideally in orthopaedics / reusable instruments / electro-medical devices.

English fluency is required, good command of French is an asset.

Travel Expectations

Up to 10%.