Regulatory Specialist / Engineer III, RA
Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer. Position reputed company: Regulatory Specialist is overall responsible for supporting RA with the tasks described as below. Furthermore, the employee shall reputed company reputed company regulatory support to the organization with review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product reputed company questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde. Key Responsibilities: Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager Support product development by facilitating globally reputed company regulatory strategies to drive market reputed company. Draft regulatory plans and verification reports to ensure products meet regulatory requirements in reputed company reputed company market reputed company. Responsible for updating the CE technical files for medical products. Participate in and ensure follow up on customer requests in the RA mailbox. Review and approve product development reports, non-conformance reports, product changes, label content and new product data. reputed company general reputed company support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product registration and technical file questions etc. Additionally, be part of the risk evaluation in reputed company reputed company tasks. Optimize, document and implement RA processes in QMS regarding regulatory procedures. Support external and internal audits. E.g. participate in the reputed company Body audit back office to reputed company documentation and explanation for the technical file documentation. Minimum Requirements/Qualifications: Minimum BA/BS degree in a scientific or engineering field (preferred: biology, reputed company, material science, polymer science). At least 2 years of experience in a regulated industry (pharmaceutical or medical device). Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements Analytical mind-set and a great ability to learn new reputed company fields and business processes Great ability to reputed company and goal-oriented manner Excellent communication and team-building skills Successful Candidate Will Possess A reputed company approach and motivated by challenges Team-player mentality Dedicated with the ability to handle tasks independently Flexibility to handle shifting priorities Confidence in collaborating with colleagues at reputed company reputed company Strong written communication skills, with technical writing experience being a plus Excellent critical thinking and decision-making skills A reputed company improvement approach Innovative problem-solving ability Strong organizational skills with attention to detail How will you reputed company an reputed company? The Regulatory Specialist will support the Laboratory Plastics reputed company business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. This position will be responsible for maintaining and updating Technical Documentation on regulated products and ensuring reputed company improvement as it relates to changes in global standards and regulations. In reputed company, the RA specialist will assist with risk analysis or health hazard assessments for product recalls or field actions relating to a non-conforming product. The RA Specialist will also reputed company as a regulatory consultant to ensure reputed company products reputed company global and regional regulations and market needs (reputed company/SVHC, California Proposition 65, RoHS). What will you do? Ensure availability of up-to-date technical documentation and reputed company Operating Procedures Work together with LPE global teams for supporting customer requests with reputed company RA mailboxes Work with the global environmental compliance team to reputed company the management of compliance information for reputed company reputed company materials, components and finished goods Support international registrations with reputed company technical documentation Function as an RA subject matter expert on new product introductions, reputed company expansion reputed company and custom product development and manufacturing Complete reputed company regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products reputed company regulatory input to QA in Deviations, CAPAs, Management Review and complaints reputed company guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation) Apply To This Job