
Dental Technology Product Lead
13 hours ago
About the Role
We are seeking an experienced Technical Product Manager to lead the full product development process, ensuring our solutions align with clinical needs, market demands, and regulatory standards (MDR, FDA, ISO 13485).
This role involves driving innovation while ensuring compliance and product excellence. You will work cross-functionally with R&D, regulatory affairs, production, and marketing teams to bring high-quality products to market.
Key Responsibilities
- Full Lifecycle Product Management – Lead product development from ideation to market release, ensuring compliance, feasibility, and clinical relevance.
- Clinical & Technical Expertise – Act as the primary point of contact for product-related inquiries, modifications, and manufacturing challenges.
- Regulatory & Compliance Leadership – Develop and maintain MDR technical documentation (CERs, PMS, risk management) to support regulatory approvals.
- Project Management & Stakeholder Coordination – Lead technical and regulatory projects, ensuring seamless transitions from development to commercialization.
- Audit & Inspection Readiness – Represent us in regulatory audits and inspections (FDA, Medical Products Agency, Notified Bodies).
- Product Launch & Quality Assurance – Ensure all products meet global regulatory and quality standards before market release.
Qualifications & Experience
- Degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Dentistry, or Business
- Experience in the Medical Device Industry, particularly with GMP, GDP, and regulatory-driven manufacturing.
- Regulatory Knowledge, including ISO 13485, ISO 14971, and MDR 2017/745.
- Hands-on approach, with the ability to manage product development from start to finish.
- Strong collaboration and communication skills, with experience working across R&D, regulatory, production, and marketing teams.
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