European Union Regulatory Affairs, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
The RA Manager will implement and manage regulatory activities related to the approval of new medical devices into the worldwide market. Provide guidance to product development teams on regulatory issues for the planning and compilation of critical documentation relating to the design verification and validation activities required in support of worldwide regulatory submissions. Serve as project leader for worldwide product registration. Ensure regulatory compliance with QSR, ISO, IVDD/IVDR and other worldwide regulations as appropriate.
Essential Duties and Responsibilities:
Participates on product development core teams as the regulatory representative with responsibility for determining worldwide regulatory submission requirements, developing and implementing product-related regulatory strategies and plans.
Define, monitor and receive deliverables for U.S. and International submissions and write, edit, and/or review these submissions using existing templates or newly created templates.
Prepare and submit International regulatory applications and filings including US FDA 510(k) submissions, Technical Files, Summary Technical Documents (STED) and Design Dossier submissions, as well as prepare internal regulatory file documentation
Provides regulatory guidance on change control, risk analysis, labeling, manufacturing, and verification and validation study plans and other relevant subject matters to ensure ongoing compliance in support of regulatory submissions.
RA team lead on the review of advertising and promotional materials (as needed).
Mentor quality staff and other relevant stakeholders within Agendia on best practices regarding the development of advertising claims and promotional practices.
Write and implement regulatory procedures for continuous improvement.
Monitor and assess product design and process changes for regulatory reporting impact and compliance. Compile evidence, prepare, submit and track regulatory reporting according to requirements of regulating bodies.
Ensure compliance with regulations (e.g., US FDA QSRs, Europe IVDD/IVDR/MEDDEV 2 12-1, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
Interact with regulatory agencies and third-party accrediting bodies to facilitate product and change approvals (as needed).
Participate as a subject matter expert (SME) during FDA, Notified Body, and other regulatory related inspections and audits as it relates to Regulatory reporting compliance (as needed).
Obtains regulatory documentation including device licenses, FDA device listings, import/export certificates as applicable.
Works with QA management and other departments to ensure regulatory compliance with the company’s Quality Management System.
Listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position
The RA manager will work with various areas of the organization; he/she works especially close with other department managers or directors.
The RA Manager should work independently with department managers and directors closely to facilitate cross-functional activities as needed as well as close interaction with inside and outside agencies
Bachelor’s degree or equivalent in science or related field required.
Regulatory Affairs Certification preferred.
Additional coursework in regulatory or quality assurance strongly desired.
BS in Life Sciences, Engineering, or equivalent required
Minimum of 5 years previous experience in regulated industry with a strong knowledge of global regulations and their interpretation relevant
Minimum of 3-5 years in a regulatory affairs leadership role
Experienced in authoring submissions or technical documentation such as 510(k), PMA, design dossiers, STED, 30-day notices, etc.
Strong and effective communicator across various levels, and with both internal and external stakeholders.
Strong knowledge of IVD/Medical Device labeling requirements and FDA 21 CFR 820.
Experienced in interfacing with domestic and international regulatory authorities.
Strong knowledge of U.S. FDA regulations governing the advertising and promotion of medical devices.
Experience working with or understanding of advertising and promotion regulations in other global markets (e.g. the EU, Australia, Canada, Japan).
Knowledge of CAP and CLIA laboratory requirements
Ability to travel internationally up to 35%
This position requires no supervisory responsibilities but will work with giving guidance to several departments
General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Maintains a clean, neat, and orderly work area.
Adheres to Department Specific Safety Guidelines.
Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10 pounds.
Internal Number: 04300-92718
About Agendia, Inc.
We were founded in 2003 as a spin-off from the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital in Amsterdam, for the purpose of commercializing molecular diagnostics using DNA microarray technology for cancer diagnosis and drug development. In 2004, we launched our first test, the MammaPrint® 70-gene breast cancer recurrence assay in Europe. In 2007, MammaPrint became the first IVDMIA to obtain 510(k) clearance from the FDA, and after receipt of the regulatory clearance, was made commercially available in the United States in 2008. Since the initial 510(k) clearance, MammaPrint has received four additional FDA clearances. Our sixth and most recent 510(k) clearance for MammaPrint® FFPE was received in February 2015.
In 2009, a significant landmark in our commercial development was our positive local coverage determination by the Medicare carrier in California which processes all of our Medicare reimbursement claims.
MammaPrint is the fastest growing breast cancer recurrence assay and has helped over 48,000 patients from almost 50 countries.