Grifols Shared Services North America, Inc Regulatory Affairs Specialist 2 in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Regulatory Affairs Specialist 2 responsible for domestic and international regulatory activities associated with FDA, Notified Body in EU, and other international regulatory agencies. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.
Primary responsibilities for role:
Prepare, compile and publish electronic pre-market and post-market regulatory submissions for FDA (CBER) including IND, BLA, Prior Approval Supplement, CBE/CBE-30 supplement, annual Report and Type B/C Meeting Requests.
Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark.
Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.)
Interact with FDA, write responses to information requests, compile complete response letters.
Participate in the preparation of 510(k), PMA and PMA Supplement submissions for FDA (CDRH).
Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.
Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance.
Develop and/or revise regulatory procedures.
Provide regulatory support to existing and new cross-functional product core teams.
Review new product design protocols related to verification and validation, risk assessment, etc.
Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
Master’s Degree and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
Demonstrated ability to coordinate complex projects.
Strong oral and written communication and presentation skills
Solid working knowledge of the US Regulations and European IVD and medical device directives
Good analytical and problem solving skills.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Experience with (US) Biologics and IVDs highly desirable.
Capacity to communicate regulations to technical functions within the company.
Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)
Solid computer skills in Microsoft Office.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home