Marcus Dumas Email & Phone Number

Gothenburg, SE

Watford, Hertfordshire, GB

• Compiling, reviewing and approving, as required, regulatory dispatches in accordance with global requirements to ensure appropriateness and consistency in content and presentation of information, with particular focus.
• Completing the requirements of the Registration Programme as agreed with the Orthopaedics R&D and Operations departments with respect to the FDA
• Providing ongoing regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
• Liaise with external regulatory authorities to ensure approvals are acquired in line with the launch plan
• Reviewing and approving change control impact assessments, product reviews ensuring registration is maintained

Watford, Hertfordshire, GB

• Providing support for internal and external audits
• Provides regulatory guidance and direction as a core team member to the development and manufacturing teams, as well as compliance projects, throughout the product development life-cycle, and identifying cross.
• Developing and implementing regulatory strategies for new and modified products and regulatory processes, and preparing submissions to obtain and maintain global regulatory approvals of products, providing oversight of.
• Ensuring regulatory compliance throughout the product lifecycle by assessing product changes for impact to global market registrations
• Assisting in preparation and authoring of FDA submission packages, EU design dossiers and technical files for regulatory agencies

Irvine, CA, US

• Responsible for the compilation, submission and maintenance of 510(k) pre-market notifications and international regulatory filings
• Serving as a regulatory representative in project development teams to develop a global regulatory strategy to ensure timely market access of new products
• Coordinating worldwide product licensing activities including the gathering of data and the submission of registration documents to in-country Edwards Lifesciences Representatives
• Ensuring promotional material are compliant with the product regulatory clearances/approvals
• Engaged in the implementation of new regulations and global regulatory requirements
• Driving document writing and review processes

Irvine, CA, US

• Lead the development and completion of Clinical Evaluation Plans/Reports (CEPs/CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates.
• Working in a cross-functional team and draft clinical investigation plans (CIPs), clinical study reports (CSRs), investigator brochures (IBs), and Annual Progress Reports
• Providing support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)
• Collaborate with the Quality organization and perform Clinical Risk-Benefit Analysis (CRBAs) to support risk management activities

Irvine, CA, US

• Conducting scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
• Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies
• Coordinating and managing the review process, leading discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
• Conducting literature searches and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders
• Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
• Contribute to post-market surveillance activities by keeping abreast of newly published scientific literature on assigned devices and report to complaint handling unit, as required

Minneapolis, MN, US

• Developing and executing global regulatory strategy for new and modified medical devices
• Preparing regulatory submissions and presentations like pre-submissions, IDEs, 510(k)s, Technical Files to FDA and Notified Bodies
• Supporting business unit in revision and development of processes and procedures for, and implementation of, new and revised regulatory requirements based on either changes in the business or regulatory requirements
• Partner regularly with marketing, engineering, clinical and quality on project and product development teams
• Advising personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
• Providing regulatory input to product lifecycle planning

Minneapolis, MN, US

• Supporting product engineering teams on regulatory issues, including review of design input, risk management and test documentation
• Evaluating new product concepts and changes to existing products including changes to design, indications, material, labelling, and packaging
• Assessing the impact of the product/process changes and determine regulatory pathway for US and EU markets
• Gathering information from international counterparts for ROW regarding the new products or impact of changes to existing products and work with international counterparts to coordinate global regulatory.
• Preparing internal documentation, and preparing and submitting regulatory filings for the above markets including non-filing justifications, 510(k)s, and Technical File updates

Master'S Degree, Bioengineering And Biomedical Engineering

Bachelor'S Degree, Biomedical/Medical Engineering