Danaher Corporation Regulatory Affairs Manager in Kloten, Switzerland
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
- The RA Manager is responsible for all EU/US regulatory affairs deliverables linked to new product development, compliance projects and the management of lifecycle management activities in close cooperation with the development teams and lifecycle maintenance teams for the Nobel Biocare product portfolio (ranging from implants and instruments to regenerative biologics) including third party manufacturer products:
- The RA Manager is expected to have up-to-date knowledge of the current US/EU legislative environment to ensure legislation in EU/US and associated policies, guidance documents and standards are adequately applied and executed in projects and maintenance activities.
- The RA Manager will be responsible for developing and executing regulatory strategies for development projects developing products intended for EU/US markets and compliance projects for products in EU/US markets.
- Develop and provide independent regulatory guidance, with low supervision, to development and lifecycle maintenance teams in terms of strategic planning, pre-marketing requirements, and related submissions to support optimal timelines and required compliance levels for new/modified product launches.
- Conduct regulatory assessments regarding requirements and timelines for product approval/re-approval for CE/US in close collaboration with the product development group and lifecycle maintenance teams.
- Support internal and external audits and inspections including preparation and closure of audit outcomes.
- Assess, review and approve of marketing communication material (IFU, leaflets, brochures).
- Contribute to development and improvement of design control and regulatory related processes and drive improvement projects for regulatory processes and procedures.
- Train, assist and provide guidance to other RA team members and other departments and stakeholders to ensure continued regulatory compliance.
- Monitor project progress and provide reporting on a regular basis to senior management to ensure timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities.
- 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.
- Maintain and develop relevant regulatory SOPs and work instructions.
- Minimum 3 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.
- Experience in preparation, submission of US regulatory files (510(k)s, PMAs) and interface with FDA during review process is an advantage.
- Experience in preparation of technical files required, and design dossier an advantage.
- Experience of devising regulatory strategies and conducting assessments for CE/US markets is required.
- Experience in preparing, supporting notified body audits including technical file and QMS audits and FDA inspections is an advantage.
- Experience of analyzing and applying harmonized medical device standards.
- Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
- 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.
- Knowledge of EU and US medical device regulations. Further markets is an advantage.
- 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.
- Fluency in 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.
- Ability to work in an international matrix organization.
- Solutions and customer focused.
- Project managements skills is an advantage.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland.
For agencies: please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002513