Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed product designed to improve human health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies, including Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc.

Grifols Inc. is the company that sets the corporate policies of all Grifols companies in the US (Grifols Biologicals, Biomat USA and Grifols USA). Also, it provides shared services on Human Resources, Information Technologies, Accounts Payables, Controlling, Audits, Planning and Finance and Regulatory Affairs. This company has an immediate opening for a Regulatory Affairs Manager offering an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and generous paid time off.

Position Summary:

• Reports to the Regulatory Affairs (RA) Director.  Incumbent must have excellent written and verbal communication skills, be well-organized, very detail-oriented, and be able to multi-task.  The incumbent must be able to interact effectively within project teams to achieve group goals; and must have the ability to withstand pressure when work priorities change and/or timelines accelerate. The position requires negotiation of project completion timelines with internal commercial and external project leaders.  Position requires continuous scheduling of activities and projects as demands and target dates change.

Job Responsibilities:  (This job description is accurate at the date of publication and may change over time.  It is not intended as an exhaustive description of the job.  Other duties may be assigned and qualifications required may change.)

• Responsible for the planning, review and preparation of In Vitro Diagnostics (IVD) documents for pre-IDEs, premarket notification or 510(k), and BLA submissions to the CDRH, CBER, U.S. FDA. 
• Review IVD performance studies for autoanalyzers and other clinical automation and analysis instrumentation, and diagnostic test kits related to immunology, blood banking, hemostasis and clinical diagnostic test kits in general.  
• Be familiar with FDA-required standards, e.g., EP-A2, EP6-A, EP7-A2, EP9-A2, EP17-A.
• Review FDA IVD guidance documents and update management of changes in the regulatory requirements which will impact the company.
• Project planning – write project plans with target due dates to complete milestones.  Monitor changes, inform relevant parties involved.  Solve problems, take actions as required, and work in an efficient manner to ensure milestones are met by target dates.
• Represent the department in meetings, both regulatory and commercial in nature. Interact effectively with quality, regulatory, research personnel within the company, internal business managers and external suppliers/distributors in order to complete projects in a timely manner.
• Prepare electronic 510(k) submissions.
• Train personnel and write regulatory SOPs.

Required Skills, Experience & Education:  (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• Mimimum of B.S. degree required.
• 5 years minimum experience in regulatory submissions in the in vitro diagnostic device industry, preferably in immunology, blood banking, clinical chemistry and hemostasis, and with both instrumentation and reagents.   
• Strong computer skills required.  Knowledgeable in Access, Word, Excel, Statistical software, e.g., Analyse-It 
• Excellent verbal and written communication skills – must have technical writing ability.
• Strong interpersonal skills with ability to interact with personnel at all levels.
• Must be capable of multi-tasking with the ability to work well with others in a TEAM environment.