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The Position
Relocation benefits are not available for this job posting.
Position Summary:
The Regulatory Affairs Specialist performs regulatory affairs team support activities in an advanced capacity by supporting, compiling, and at times leading regulatory submissions, executing critical regulatory interpretation activities, collaborating on regulatory strategy activities with the Regulatory Affairs (RA) team and the RA Leadership Team (RALT), and supporting a variety of RA team projects as needed. This may also include internal regulatory review, gap analysis, project planning support, functional initiatives, and other tasks as needed. This role will require open, transparent, and fluid communication with points of contact on the RA team and with the RALT, as well as transparent project and task mapping, to ensure comprehensive integration into the broader FMI Regulatory Affairs team.
The Opportunity:
* Lead and Support Regulatory Activities: Represent the Regulatory Affairs function on cross-functional project teams, including interactions with health authorities and biopharmaceutical partners. Contribute to and support regulatory strategy for in vitro diagnostic (IVD) and companion diagnostic (CDx) devices in the US, EU, Japan, and RoW.
* Author and Manage Regulatory Submissions: Prepare, draft, edit, and publish FDA and global regulatory submissions (e.g., SRDs, IDEs, Pre-Subs, PMAs, sPMAs, 30-day notices), including technical documentation, validation reports, and clinical protocols. Collaborate with SMEs to ensure submission quality and compliance.
* Maintain Regulatory Compliance: Review engineering changes, labeling, promotional materials, and product modifications for regulatory compliance. Evaluate the regulatory impact of changes and lead change control activities that require regulatory agency approval.
* Support Post-Market and Lifecycle Management: Contribute to post-market surveillance (e.g., PMS reports, post-market clinical follow-ups, annual reports), and manage regulatory support for marketed products and product changes across global markets.
* Drive Process Improvements and Knowledge Sharing: Lead and support functional initiatives, process optimization, submission documentation management, and systems integration to enhance regulatory operations and team efficiency.
* Monitor Regulatory Landscape and Ensure Readiness: Stay current on evolving global regulatory requirements and proactively recommend updates to processes, documentation, and strategy to maintain compliance.
* Support Strategic Projects and Quality Initiatives: Participate in long-term regulatory affairs projects, standards updates, and quality system enhancements to support both operational and strategic goals.
Who you are:
* Bachelor’s Degree in device, biotechnology, or pharmaceutical regulatory affairs – OR - sufficient, commensurate experience and certifications.
* Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting Pre-Sub, IDE applications, and/or PMA documents to FDA CDRH.
* Regulatory compliance knowledge of IVD requirements under FDA, IVDR, PMDA (Additional global regulatory experience desirable).
* Understanding of validation design typical for FDA IVD submissions.
* Demonstrated ability to work cross-functionally on complex projects involving assay, instrumentation, and software.
* Familiarity with device design control process and regulatory role in process.
* Experience attending meetings with regulators including FDA, Notified Bodies.
* Ability to understand and interpret clinical data.
* Expertise in regulatory strategy.
* History of successfully managing multiple concurrent regulatory submissions.
* Outstanding interpersonal skills, including excellence in written and oral communication, negotiation, collaboration, and problem-solving.
* Excellent cross-functional collaboration skills.
* Strong attention to detail and organizational skills.
* Understanding of HIPAA and the importance of patient data privacy.
* Ability to maintain confidentiality on company matters.
* Commitment to FMI’s values: passion, patients, innovation, and collaboration.
Who we are
A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
The Roche Services & Solutions as well as People Support Solutions organizations located in San Jose provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources), and beyond to our Roche colleagues across the Americas region. Today, Roche employs around 800 employees in Costa Rica.
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