Grifols Shared Services North America, Inc Regulatory Affairs Specialist II in San Diego, California
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. Education
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. Experience
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. EEO Minorities/Females/Disability/Veterans Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.
Req ID: 178349