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Product Development Manager
2 weeks ago
We are a leader in dental innovation, shaping the future of dental technology.
Job DescriptionKey Responsibilities:
- Full Lifecycle Product Management – We're looking for an experienced professional to lead product development from ideation to market release.
- Clinical & Technical Expertise – As our primary point of contact, you'll act on 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.
- 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.
