Grifols Shared Services North America, Inc Regulatory Affairs Specialist 1 in San Diego, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has nearly 18,500 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
The Regulatory Affairs Specialist I will be responsible for assisting in the management of all regulatory activities including regulatory submissions for the registration of IVD systems (assays, instruments, software).
Primary responsibilities for role:
Assign and track deliverables for submissions from submission content subject matter experts.
Write, edit and/publish various types of submission documents to FDA and EU regulatory bodies, including but not limited to INDs, BLAs, Annual Reports, CBE-30s, Technical Files, and Design Dossiers.
Coordinate and prepare responses to deficiency letters or requests for additional information from competent authorities
Assess manufacturing process, design, and labeling changes for regulatory reporting impact.
Keep informed of new and revised regulations; disseminate information as appropriate (i.e. FDA guidance, IVDR, international standards, etc.)
Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle.
Identify and communicate potential risks of regulatory pathways to the stakeholders. Work on mitigation plans to reduce regulatory risk when applicable.
Interface collaboratively with partners and local liaisons for management of submissions in foreign countries.
Bachelor's Degree required in the life sciences or engineering with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
Master’s Degree and/or RAC preferred with a minimum of 1-3 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
Understanding of medical device and IVD regulations in US and EU.
Understanding of product life cycle process, design control and/or risk management.
Experience using Microsoft Office and Adobe
Effective technical writing and verbal communication skills.
Ability to work effectively as part of a cross-functional team with limited supervision
Ability to work in a fast paced environment with shifting changes in prioritization based on regulatory and business needs.
Good analytical and problem solving skills.
Ability to learn in a fast-paced environment.
Ability to make and keep time bound commitments for project completion.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Understanding of FDA and CE, and IVD regulations. Specialized knowledge of CBER regulations is desirable. Specialized knowledge of IVDR is desirable. Working knowledge of the medical device product lifecycle. Product design and manufacturing change assessments for regulatory reporting. International regulations and submissions.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 72241
Type: Regular Full-Time
Job Category: Regulatory Affairs