Performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Experience Level with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired. Typical Education and Experience: Bachelors degree (or equivalent experience) and 5 years of related experience or Masters Degree with 3 years of related experience.
Must have experience with Medical Device - RA,,, Experience with Implantable or Sterile Medical Devices is a big plus.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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