Join Our Team as a Senior Regulatory Affairs Design Quality Engineer
To strengthen our Regulatory Affairs and Quality Assurance department and support our business expansion, particularly in the USA market, we are seeking a talented Senior Regulatory Affairs Design Quality Engineer. Reporting directly to the Regulatory Affairs Manager, you will play a critical role in our commitment to compliance with applicable regulatory requirements across various regions including the EU, US, AU, UK, and CH.
Key Responsibilities
- Regulatory Interactions: Serve as the primary point of contact for interactions with Competent Authorities (such as ANSM, FDA, TGA, MHRA, Swissmedic) and our European Notified Body. Prepare and defend Symbios' technical and regulatory positions in relation to pre- and post-market submissions, audits, inspections, and any regulatory queries.
- Design and Development: Collaborate with Engineering teams to ensure the design and development of medical devices meet regulatory requirements and established standards. Participate in risk management activities and review quality records for compliance.
- Compliance: Provide essential support for Quality Management System (QMS) processes managed by the regulatory team, ensuring adherence to Change Control, Risk Management, and CAPA processes. Act as a process owner to maintain compliance and drive continuous improvement.
- Regulatory Intelligence: Interpret and implement medical device regulations, including FDA QMSR and EU MDR, and lead their deployment within the organization.
- Cross-functional Collaboration: Foster effective communication and collaboration across Engineering, Operations, Marketing, Quality, and Clinical Affairs by acting as a regulatory/quality expert and ambassador.
Your Profile
- Engineering or Master's degree (or equivalent) with a minimum of 7 years of significant experience in the Medical Device industry, preferably in orthopedics.
- Strong knowledge of medical device regulations (EU-MDR and FDA QMSR) and guidance documents.
- Demonstrated experience in direct interactions with Competent Authorities and/or Notified Bodies, with the capability to prepare and defend regulatory positions.
- Solid background in problem-solving and manufacturing change control within EU and US Regulations.
- Experienced in compiling and submitting technical dossiers, including 510(k) submissions.
- Familiarity with ISO 14971:2019 for risk management and associated tools.
- Knowledge of software-related regulatory requirements is a plus.
- Results-oriented with a track record of timely delivery within defined scopes.
- Able to manage multiple projects and prioritize effectively while proposing pragmatic solutions.
- Analytical, rigorous, autonomous, and collaborative.
- Excellent communicator with the ability to adapt messaging for various audiences while remaining factual and precise.
- Fluency in French and English; proficiency in German is an asset.
- Preferably located in French-speaking Switzerland.
If you are interested in this challenge, apply online using the form below. Please note that only applications matching the job profile will be considered.