3 Ivdr Jobs

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments. Connects and actively interacts with Medical Device Industry forums. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Adheres to internal standards, policies and procedures.

Role & responsibilities Job Summary : We are seeking an experienced and highly motivated IVDR Technical Manager to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. Key Responsibilities : Competence Management Manage the competence process for all technical roles as per the accreditation and regulatory requirements in DNVs procedures. This includes the initial qualification as well as maintaining them. Cross-team Collaboration Work closely with the sales and planning functions, as well as other key internal stakeholders to enhance the operational cooperation and interaction within the IVDR services delivery and promote best practice sharing. Ensure to provide or address technical support when needed to the same functions. Proactively identify and recommend process improvements. Compliance and Regulatory Updates Work with cross-functional teams to ensure all stakeholders are informed of IVDR requirements and compliance statuses. Stay updated on changes in IVDR, EU regulatory requirements, and industry best practices. Provide training and support to internal teams regarding IVDR compliance and regulatory updates. Team Development and Training Ensure the team have all the knowledge needed to carry out work to a high level. When and where required, identify training and development to guarantee there is a culture of continuous performance, Take part and be responsible for the hiring of new staff. Recognizing where the gaps are and building a team that is motivated, talented and diversified. Design an on-boarding program for new staff that is varied, engaging and ensures they are set up for success, Business Development Drive and implement the sales and business development initiatives to promote Medical certification services, Interface with customers and follow up on leads and sales conversions Addressing technical queries with customers Preparation of effort estimations and commercial proposals Lead generations through public webinars/workshops, representation on relevant forums Customer Relationship Management Building trusted relationships with customers and internal stakeholders Communication with customers on the execution status of the certification activities. Preferred candidate profile Education : Bachelors or Master’s degree in Life Sciences, Engineering, Medical Technology, or a related field. Experience : At least 10+ years of experience in regulatory affairs, technical documentation, or quality management in the medical device or in vitro diagnostics industry. At least 4 years of direct experience with IVDR or its predecessor, IVDD (In Vitro Diagnostic Directive). Experience in preparing and submitting technical files, design dossiers, and risk management documentation for IVD products. Skills & Competencies : Strong understanding of the IVDR and EU regulatory requirements for IVD products. Excellent knowledge of technical documentation practices, including risk assessments, clinical evaluations, and performance studies. Knowledge of ISO 13485 and other relevant standards for medical devices/ invitro devices. Experience working with Notified Bodies and regulatory authorities. Exceptional problem-solving and analytical skills. Excellent organizational and time management abilities Strong communication and project management skills, with the ability to work collaboratively in cross-functional teams. Experience in auditing for IVDR compliance. Relevant exposure to commercial activities/business model.