Regulatory Affairs Manager

Description

• Lead development and execution of regulatory strategies for Prosthetics & Digital development projects for market access to EU / UK / CH, US & CA, compliance projects and lifecycle management activities and ensure all RA related elements & requirements are implemented.
• Assembling, and ensuring quality of the deliverables related to CE / UKCA marking, 510(k) submissions and Health Canada submissions for Prosthetics & Digital devices and workflows.
• Represent the RA function in software integration or digital workflow implementation projects for market access to EU / UK / CH, US & CA.
• Provide regulatory input and technical guidance on respective regulatory requirements to project teams.
• Revise or create Technical Files and review to ensure they are in compliance with procedures and consistent and that the input documents fulfill regulatory requirements.
• Evaluate the regulatory environment and contribute by providing advice throughout the product lifecycle to ensure product compliance.
• Evaluate proposed change requests and drive the regulatory implementation of change requests.
• Provide regulatory information and guidance for proposed product claims / labeling. Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
• Review of labels and IFUs.
• Support internal and external audits through audit preparation, audit back-office or in audit front office. Proactively plan and organize audits and ensuring audit team and SMEs are appropriately trained.
• Creation and maintenance of regulatory procedures and templates. Identification of updates required for compliance, correctness, interaction or efficiency reasons, as well as need for any new procedures.

LI-EU1

Job Requirements :

Critical Knowledge and Qualifications :

A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage.

A degree focused in technology or science is preferred.

• In depth knowledge of core aspects of the medical device quality management systems 21 CFR Part 820, ISO 13485 and MDSAP.
• In depth knowledge of core aspects of the MDR including classification, technical file requirements and GSPRCs. Overview knowledge on remaining areas including country specific requirements.
• In depth knowledge of core aspects of US and CA regulatory system set-ups, classification methods and submission principles.
• Knowledge of core aspects of the design control process requirements and requirements for technical documentation for medical devices.

Critical Skills / technical know-how :

• Fluency in English a must. German or further languages is an advantage.
• Able to communicate effectively with stakeholders, ensure understanding, alignment on issues questions and goals.
• Able to work in teams and to build up a multidisciplinary network. Contribute to building a respectful, diverse and inclusive workplace, where decisions and transactions are transparent and fair.
• Able to support decision making process and establish basis for selection of solutions.
• Capable to plan out daily work to deliver on time, able to make adjustments when required and prioritizing work.

Critical Experience :

• Minimum 4-5 years' experience in regulatory affairs within medical device industry.
• Minimum 3 years' experience in working directly with authorities.

Operating Company : Nobel Biocare

Nobel Biocare

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