Regulatory Affairs Specialist 3 - Medical Device IVD

About the role

Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The role involves ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. Key responsibilities include developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications, and managing communications with health agencies.

Responsibilities

• Prepares and files complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies, as applicable.
• Tracks submissions, correspondence, and commitments with health authorities and prepares responses and comments from regulatory agencies independently, proactively, in compliance with regulatory guidelines/requirements and according to established timelines.
• Develops and executes submission strategies based on ability to understand complex technical information, and provides guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market.
• Maintains progress on key project deliverables and provides status updates to management on a regular basis.
• Collaborates with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborates with partners and local liaisons for management of submissions in foreign countries and facilitates meetings with SMEs as needed to track progress.
• Executes projects without supervision to align with and achieve the goals and timelines set by management.
• Makes decisions and influences stakeholders and teammates based on gained regulatory knowledge and experience, technical expertise and current regulatory compliance trends.
• Communicates moderately complex to complex regulatory topics to cross-functional management, modifies their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels.
• Proactively researches applicable regulations and guidance to the company’s products and stays up to date on the current regulatory requirements and industry trends. Assesses the impact of applicable regulations to the company’s products and identifies mitigation plans, leads mitigation projects, and makes decisions that will assist in reducing regulatory risk.
• Reviews, provides regulatory input to, and approves various quality management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory requirements are being adequately addressed.
• Provides support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes.
• Affirms changes to product for regulatory impact and includes regulatory assessments in the established change control systems, as applicable.
• Prepares regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests.
• Identifies process improvement initiatives and drives their successful execution.
• Provides regular status updates on projects to management.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field.
• At least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs.
• Prior experience in the IVD or Drug/Biologics industry is required.

Qualifications

• Demonstrated ability to independently coordinate and manage complex projects, prioritize multiple responsibilities and drive projects to completion.
• Demonstrated ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
• Demonstrated interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
• Demonstrated ability to identify issues, understand their urgency, escalate to management, and provide solutions.
• Demonstrated understanding of IVD regulations, advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
• Strong oral and written communication and presentation skills, capable of presenting and explaining complicated concepts to colleagues within the organization.
• Strong technical writing skills with ability to translate scientific information into technical documentation for submission to regulatory authorities.
• Demonstrates expert attention to detail with ability to identify areas of improvement and possible inconsistencies in documentation.
• Expert analytical and problem-solving skills, capable of identifying problems, determining root cause and providing solutions to management.
• Demonstrated ability to communicate with FDA and international customers (e.g., regulatory agencies, business partners, etc.).
• Exceptional computer skills in Microsoft Office, Adobe, Excel.
• Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA, required.