Regulatory Affairs Manager

• Development and execution of regulatory strategies for development projects, product change projects, compliance projects and lifecycle management activities.
• Develop and provide independent regulatory guidance to project teams in terms of premarket requirements and related submission to support optimal timelines and required compliance levels for product development and compliance projects.
• Ownership of systems and procedures required for compliance in EU, US & CA including ensuring consistency in classifications, strategies and documentation.
• Establishing and maintaining processes allowing compliant and timely submissions for new launch projects and compliance projects.
• Ensuring timely maintenance activities for all registrations, listings, schedules, sampling plans, submissions, technical files and article information in EU, US & CA.
• Providing regulatory input to cross-functional project teams including global impact assessments.
• Review and approval of product related labeling, IFUs, marketing material and associated claims.
• Assessment, approval and regulatory implementation of change requests.
• Contribute to development and improvement of design control and regulatory related processes, ensuring that near misses, nonconformities and lessons learnt are monitored and systems and procedures updated to prevent re-occurrence.
• Monitor closely and provide guidance and awareness of guidelines, regulations, changes in the marketplace and regulator positions and other information relating to global regulatory compliance for the assigned markets.

• 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 EU, US and CA medical device regulations. Further markets is an advantage.
• Knowledge of international regulator operations, priorities and plans.
• In depth knowledge of design control process requirements and requirements for technical documentation for medical devices.
• Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485
• Knowledge in documentation requirements and processes for CE and US submissions.
• Knowledge of quality and regulatory systems and processes from a system perspective.

• Fluency in English a must. German or further languages is an advantage.
• Excellent communication skills verbally and written, with multicultural sensitivity.
• Highly organized, flexible, with ability to multitask and work under strict time lines.
• Strong interpersonal skills and team player.
• Pro-active and positive working attitude.

• Minimum 4 years’ experience in regulatory affairs within medical device industry.
• Experience in developing and reviewing as well assuring required compliance of design control and associating technical documentation and preparation of technical files required, and design dossier an advantage.
• Experience in preparation, submission of US regulatory files (510(k)s,
• Experience of devising regulatory strategies and conducting impact assessments.
• Experience in preparing, supporting notified body audits including technical file and QMS audits and FDA inspections is an advantage.
• Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.

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