Regulatory Affairs Specialist

Smith & Nephew (Switzerland) seeks a mid-level Regulatory Affairs Specialist in Zug for part-time work, focusing on MDR compliance, global submissions, and technical file management for orthopaedic products.

This position serves as the primary regulatory liaison for Smith & Nephew Orthopaedics AG, ensuring that medical device submissions meet international standards. The specialist manages the lifecycle of regulatory filings, coordinates with notified bodies and global authorities, and supports the implementation of harmonized regulatory processes across various regions.

Responsibilities

• Manage and maintain regulatory submissions for Smith & Nephew Orthopaedics AG products within the EU, acting as the main point of contact for notified bodies under MDR 2017/745.
• Ensure adherence to global regulatory frameworks, including EN ISO 13485, MDSAP requirements for Australia, Brazil, Canada, Japan, and the US, alongside other applicable standards.
• Oversee worldwide regulatory maintenance and coordinate re-submissions for products, collaborating closely with country affiliates and health authorities.
• Lead change management efforts within the Regulatory Affairs department and provide support for design-related queries on both internal and global levels.
• Provide technical file support for product portfolios to ensure documentation accuracy and completeness.
• Verify that suppliers, contractors, and country representatives meet quality management system requirements for medical devices, handling contract management and necessary authorizations.
• Support the implementation and harmonization of global regulatory processes to ensure consistent compliance.

Requirements

• At least five years of professional experience in Regulatory Affairs.
• Proven background in medical device regulations, specifically EU MDR 2017/745 and MDSAP countries, with knowledge of other global regions.
• Strong communication and collaboration abilities to work effectively with diverse teams.
• Capability to manage complex projects, including coordinating various team members.
• Ability to work independently with minimal supervision.

About the company

Smith & Nephew (Switzerland) is dedicated to designing and manufacturing technology that expands the boundaries of human living. The organization fosters a supportive community that empowers both its employees and patients on a daily basis.

• Focuses on creating technology that removes limits from living.
• Operates as a community that supports and empowers employees and patients.