Regulatory Affairs Specialist - Medical Device IVD

Regulatory Affairs Specialist 3 - Medical Device IVD

Location:

CA-San Diego, US

Contract Type:
Regular Full-Time

Area: TECHNICAL

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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. This role 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.

It 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.

• 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…