- Work with R&D and sustaining engineering ensuring timely and ongoing delivery of engineering information to support the continuous updating of technical documentation and products availability on the market.
- Determine regulatory gaps regarding EU MDR, UKCA and other EVC's applicable regulations.
- Propose regulatory paths to ensure rapid and timely approval of devices.
- Continuously interpret existing or new regulatory requirements as they relate to company products and procedures, and develop the regulatory tools, SOPs, checklists and templates to ensure compliance to such requirements.
- Provide regulatory guidance and support to project teams including testing and standards requirements and support RA staff in filing process.
- Review, analyze and propose changes of technical data generated by Research and Development, Manufacturing, Marketing, Clinical Research, Quality Assurance or other related departments for regulatory filing purposes.
- Review, provide feedback from the regulatory point of view about manufacturing changes, risk management, test protocols and reports to ensure regulatory compliance with FDCA, EU MDR, UKCA, and applicable standard.
- Review promotional and advertising materials, product claims, training materials, based on global requirements.
- Review complaints for determination of reportability based on global markets requirements.
- Author US and International regulatory submissions, including, but not limited to IDE/IDE, Supplements, 510Ks, PMAs/ Supplements, Annual Reports, Technical Documentation and Change Notices. Regulatory submission experience with the EU MDR
- Direct interactions with regulatory authorities and notified bodies during product filings and reviews
- Advanced knowledge of regulatory framework and regulatory requirements for EU MDR, APAC, US
- Intermediate knowledge of product life-cycle, product development process, design control and change control
- Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, and deal with several abstract and concrete variables
- Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
- Determine the regulatory impact of proposed product changes on EU registrations
- Advise project teams on pre-market regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues
- Create/update technical documentation to achieve and maintain MDR certification
- Supporting MDR device registration efforts in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient, compliant manner
- PMA and 510k authoring
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
- Respond to requests from regulatory authorities.
- Conduct conference calls, meetings and presentations with regulatory authorities, reviewers and/or inspectors as needed.
- Develop regulatory processes and procedures as needed.
- Recruit, retain, and develop regulatory staff as needed to meet organizational needs.
- Maintain corporate confidentiality at all times
- Other duties as assigned.
- Bachelor's degree in science, life science or engineering or equivalent related experience
- High level of detail and accuracy on filings and information created and shared with other parties. Project management experience preferred.
- Must have 4-7 years of global submissions hands on experience with a successful track record of Class III US, EU MDR, UKCA, Asia Pacific filings and registrations.
- Must have an expert knowledge of US FDA, EU MDR, UKCA filings and regulations.
- Must have hands on experience in the preparation, and submission of PMAs, PMA supplements, Technical Files, Technical Documentation and amendments.
- Must have excellent verbal and written communication, presentation skills, including experience presenting at FDA meetings.
- Must be able to communicate clearly, succinctly, and effectively over the phone and in writing with various clients including Regulatory Agencies.
- Must have strong interpersonal and communication skills
- Must be able to work independently and multitask.
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Description
Overview:Euclid Vision Corporation (EVC) is seeking a Senior Regulatory Affairs Specialist to be the internal main point of contact for MDR and UKCA compliance. Reporting directly to the Director, Regulatory Affairs, the senior RA specialist will analyze and evaluate new products to ensure they comply with company and legal regulations. It's critical that the incumbent maintain knowledge of applicable and evolving regulations. The senior RA specialist will develop company standards for products in line with legal standards and company needs. The specialist will also communicate with regulatory agencies and ensure a good company relationship.
Job Responsibilities:
