Regulatory Affairs Specialist 3 - Medical Device IVD

GRIFOLS, S.A.•San Diego, CA

7d•Onsite

About The Position

Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications to FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. This role requires collaboration with cross-functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor’s degree in life sciences, engineering, or a related field, along with 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.

Requirements

This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.
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
Bachelor's Degree required in the life sciences, engineering or similarly related field
6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Drug/Biologics Industry experience required.

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. Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content according to established templates and timelines.
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. Communicates with Health Authorities and has a demonstrated ability to facilitate requests and anticipate appropriate next steps.
Develop and execute submission strategies based on ability to understand complex technical information, and provide 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. Monitor progress on key project deliverables and provide status updates to management on a regular basis.
Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress.
Execute 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, modify their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels.
Proactively research applicable regulations and guidance to the company’s products and stay up to date on the current regulatory requirements and industry trends. Assess the impact of applicable regulations to the company’s products and be able to identify mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk.
Review, provide regulatory input to, and approve 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.
Provide support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes.
Assess changes to product for regulatory impact and include regulatory assessments in the established change control systems, as applicable.
Prepare regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests
Identify process improvement initiatives and drives their successful execution
Provides regular status updates on projects to management.
Additional duties assigned as needed.