Senior Specialist, Regulatory Affairs, Medical Writing - Critical Care (Remote, USA)
- Irvine, CA
Edwards has an exciting opportunity in the Critical Care group, focused on transforming patients' lives by advancing Critical Care innovations. As Senior Specialist in this role, you will work closely with Regulatory, Quality, R&D, and Clinical professionals and other subject matter experts to create Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements. These reports will be included in the respective technical documentation file to support initial and continued CE Marking and must effectively and clearly describe research results, literature searches and reviews, product use and other required information. You will also ensure that the documents and presentations comply with MED DEV 2.7.1, rev 4 as well as MDD, MDR, and internal processes in terms of content, format and structure.
- Support regulatory submissions and other associated activities by authoring CEP's and CER's or providing input from the CER into other reports (e.g. clinical evaluation plans and reports, period safety update reports, post-market surveillance reports, Summary of Safety and Clinical Performance, etc.), including performing literature searches.
- Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional teams to understand upcoming medical writing needs and manage resourcing and assignments to ensure timelines are met.
- Provide CER author expertise and collaboration with cross functional teams including Regulatory Affairs, R&D, and Quality on Clinical Evaluation Reports and plans throughout product lifecycle. In addition, coordinate reviews with applicable Clinical Evaluators.
Required Education / Skills / Experience:
- Bachelor's + 5 years of related experience in science or engineering or Master's + 3 years of relevant writing and clinical data analysis experience required; Experience in medical device or related industry; Master's degree in related field preferred.
- Proven successful experience with Class II and Class III devices and Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) development under MEDDEV 2.7.1, rev. 4 required.
- Expert knowledge of EU Medical Device Directive and Medical Device Regulation requirements for the submission of pre- and post- market CEP's and CER's
- Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline, PubMed, Google Search)
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Expert product knowledge including current developments, clinical literature review, and therapeutic and product operation knowledge
- Maintain current, in-depth product knowledge including current developments, clinical literature review, therapeutic and product usage knowledge.
- Expert understanding of procedures while identifying applications of functional knowledge and existing methodologies to complex problems
- Expert knowledge of biomedical statistics is preferred
- Familiar with medical devices and devices that utilize software
- Strict attention to detail
- Interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
- Frequently interact with functional peer group managers, normally involving matters between cross-functional teams; often leads a cooperative effort among members of a project team
- Participate and present at meetings with internal and external representatives
- Track projects and provide project-related updates
- Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
- Develop relationships and leverage them to influence change
- Support and solicit input from team members at all levels within the organization
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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