Senior RA Specialist

Company Overview:

We are a medical device company dedicated to providing innovative and high-quality solutions to patients and dental professionals worldwide.

To further strengthen our regulatory team, we are seeking an experienced Senior Regulatory Affairs Specialist who will play a crucial role in ensuring compliance and regulatory excellence for our products.

Position: Senior Regulatory Affairs (RA) Specialist

Location: Haifa district

Responsibilities:

Regulatory Submissions: preparing submissions for regulatory authorities, especially 510(k) and conformity assessments per the EU Medical Device Regulation (MDR). Securing approvals and maintaining market access.
Regulatory Intelligence: Stay updated with the latest regulatory updates and changes in the medical device industry across relevant territories, including the US, EU, and other major markets worldwide. Monitor changes in regulations, guidelines, and standards and assess their impact on our products and processes.
RA Input in Design and Development: Collaborate with the Design and Development teams to provide regulatory guidance and ensure that RA requirements are considered throughout the product development lifecycle. Participate in design reviews and provide expert input to achieve compliance from the early stages.
EU Technical Documentation and 510K Files Maintenance: Take ownership of maintaining and updating technical documentation for products marketed in the EU. Ensure compliance with relevant EU directives and regulations. Manage and maintain 510K files for products distributed in the US.
Change Impact Analysis: Assess the impact of any product changes, process modifications, or updates to existing regulations on our regulatory strategy and documentation. Provide guidance to relevant stakeholders on the appropriate regulatory actions.
Lead RA Projects: Take the lead on specific regulatory projects, such as new product registrations, market expansions etc. Coordinate with cross-functional teams to ensure timely and successful project completion.
Additional RA Tasks: Handle other regulatory affairs tasks as required, including regulatory submissions, product registrations, preparing responses to regulatory authorities, and maintaining records of regulatory communications.

Requirements:

Minimum of 5 years of experience in Regulatory Affairs within a medical device company, with a strong focus on non-active medical devices. Proven experience in successfully navigating regulatory challenges and obtaining approvals in various markets.
Knowledge of US and EU Regulations: Thorough understanding of regulatory requirements for dental implants in the US and the EU. Familiarity with other international regulatory frameworks will be an advantage.
Change Management Expertise: Proficiency in conducting change impact assessments and implementing appropriate regulatory strategies in response to product or process changes.
Excellent English and Writing Skills: Exceptional written and verbal communication skills in English are essential for preparing regulatory submissions and maintaining documentation.
Team Player: Ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, and Marketing, to achieve regulatory objectives.
Regulatory Compliance: Demonstrated track record of ensuring products’ compliance with relevant regulations and standards.
Attention to Detail: Meticulous attention to detail in reviewing regulatory documentation and ensuring accuracy and completeness.

Education:

Bachelor’s degree in a relevant scientific or engineering field is required. Advanced degrees and certifications in Regulatory Affairs will be advantageous.