Who are we?

Eon Dental is a high-impact medical devices & tech company growing at neck breaking speed. We are a team of over ~500 colleagues dedicated to making Eon Dental a leading global player in the clear aligner and dental services industry.

Eon Dental aims to deliver value to dentists and orthodontists worldwide by offering a superior quality product, dynamic pricing, treatment schemes as well as after-sales service and assistance.

Software and innovation are involved in all aspects of our product lifecycle; beginning from an engaging experience on the frontend applications that serves customers and dentists to robust backend solutions for process management and automation.

Our excitement about the vision and mission of the company has enabled us to foster a great culture and an exciting work environment that is based on building synergies and our team’s exceptional talent to make our customers’ experience outstanding.

Your Impact

The Senior Regulatory Affairs Specialist is based in Jordan and reports to the Compliance Operations and Intellectual Property Manager. This role plays a strategic role in ensuring the regulatory compliance and market access of custom-made dental devices and SaMD. This role also leads regulatory submissions, monitors changes in global regulations, ensures conformity with EU MDR and FDA requirements, and maintains product documentation. The role is central to aligning product development, manufacturing, and marketing activities with international regulatory standards to ensure smooth commercialization of products.

What You'll Do

• Interpret international regulatory frameworks applicable to custom-made devices and SaMD, especially EU MDR Annex XIII and FDA requirements (510(k)).
• Define regulatory pathways for new and existing products and ensure classification accuracy.
• Advise R&D and design teams on regulatory constraints and risk mitigations during product development.
• Prepare and maintain documentation such as: EU MDR compliant Technical Files, FDA 510(k) submissions (if applicable) and appropriate product codes, Local regulatory submissions (e.g., Jordan Food & Drug Administration).
• Manage renewals, notifications, and modifications to product registrations.
• Support regulatory compliance of software used in digital treatment planning (e.g., cloud-based treatment simulation tools).
• Ensure alignment with standards like IEC 62304 and FDA's guidance on SaMD.
• Support the Quality Assurance team with implementation and maintenance of QMS in accordance with ISO 13485 and ISO 14971.
• Participate in internal and external audits; ensure regulatory sections of QMS are up to date and inspection-ready.
• Maintain compliant records of conformity for each custom-made device delivered.
• Monitor changes in international regulations affecting dental aligners (e.g., changes in MDR Article 5(5), UDI for custom-made devices, FDA digital health frameworks).
• Communicate relevant updates to stakeholders and assess business impact.
• Act as regulatory representative in cross-functional meetings (R&D, clinical, operations, sales).
• Deliver training sessions to internal teams on regulatory updates, compliance responsibilities, and documentation best practices.
• Take appropriate actions in relation to any hazards and work related issues, and escalate as needed, in order to ensure prompt and effective resolution.
• Perform other job-related tasks as assigned by the line manager, in order to ensure the fulfillment of organizational objectives.

What To Bring

• 5–8 years of experience in Regulatory Affairs for medical devices, with proven exposure to international markets.
  
• A Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field; a Master’s degree is preferred.
  
• Strong familiarity with EUMDR and hands-on experience with 510(k) submissions is a must.
• Working knowledge of global regulatory frameworks such as Health Canada, TGA, MDSAP, and international standards including ISO 13485, ISO 14971, and IEC 62304.
  
• Familiarity with e-submissions or Regulatory Information Management (RIM) systems.
• Excellent technical writing, documentation, and communication skills in English—both verbal and written.
• Experience with Software as a Medical Device (SaMD) and custom-made devices is a strong plus.
• RAC (Regulatory Affairs Certification) for medical devices or CMDA certification is a plus.

What We Offer

• Great culture and growth opportunity
• The chance to personally impact Eon’s customer experience
• Push your boundaries working with highly motivated and cross-functional teams

Interested?

Then apply for this position by clicking on the apply button. All applicants must send an updated CV in English.