Emily Becker Email & Phone Number

Denver, Co, Us

Denver, Colorado, Us

Denver, Co, Us

-Responsible for implementing and maintaining a global compliance program, including ensuring compliance with GDPR, CCPA, etc. -Lead the Sales and Marketing team by defining and implementing strategies to increase qualified inbound leads and increase conversion of prospects to meet revenue targets.

Chicago, Il, Us

Effectively manage the regulatory affairs consulting team to provide successful global regulatory affairs support to clients in the medical device, pharmaceutical, biologic, combination product and tissue industries. Author and lead regulatory assessments, 510(k)s, Technical Files/Design Dossiers, STEDs, pre-submissions, IDEs and PMAs in orthopedic, standalone software, ophthalmic, cardiovascular, in vitro diagnostics, anesthesiology, and more medical device therapeutic areas. Author and lead pre-IND meeting requests and INDs for pharma, biologic, and combination products in the ophthalmic, pain, imaging and more therapeutic areas. Effectively manage meetings with FDA, notified bodies, EMA and similar regulatory agencies. Proven track record to manage and perform projects to completion with the desired results on-budget and on-time. Work with a strong passion to mentor and develop regulatory and quality professionals to continue their career advancement.

Milwaukee, Wi, Us

Author complex US and OUS regulatory strategies for external clients' innovative products. Assist external clients with Regulatory submissions including 510(k)s, IDE Annual Reports, Pre-Submissions, Technical Files/Design Dossiers, Investigational New Drug (IND) applications and IND amendments, and IND annual reports, many of which performed simultaneously. Responsible for developing strategic regulatory approaches for projects, and managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to state and federal regulatory agencies under tight deadlines. Function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. Ensure that regulatory submissions are complete, properly formatted, and compliant with applicable regulatory requirements.Acting Regulatory Affairs Director for external client. Conduct gap assessments on external clients' regulatory and quality elements, such as complaint handling, MDR reporting, and HIPAA compliance program. Work with various key stakeholders in conflicted environments for successful execution of remediation activities. Provide regulatory review and approval of medical device marketing and advertising material. Author complex regulatory strategies for innovative product intended use and indications for use.Manage various regulatory affairs professionals working at external clients' sites. Management included administrative elements, as well as ensuring the projects were being completed on time, on budget, and meeting all client expectations.Assist internal clients with Regulatory matters including reimbursement, supply chain management, HIPAA compliance and pharmaceutical Patient Assistance Programs. Manage, train and mentor regulatory associates and/or quality specialists.

Milwaukee, Wi, Us

Assist external clients with Regulatory submissions including 510(k)s, IDE Annual Reports, Pre-Submissions, Technical Files/Design Dossiers, Investigational New Drug (IND) applications and IND amendments, and IND annual reports, often performed simultaneously. Responsible for developing strategic regulatory approaches for projects, and managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to state and federal regulatory agencies. Function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. Ensure that regulatory submissions are complete, properly formatted, and compliant with applicable regulatory requirements.Worked in external client's cross-functional teams to author Health Hazard Evaluations (HHE) and track and report on status of Corrective and Preventative Action (CAPA) remediation. Author complex regulatory strategies for external clients' innovative products. Conduct gap assessments on external clients' regulatory submissions and assist with remediation activities.Assist internal clients with Regulatory matters including reimbursement, supply chain management, HIPAA compliance and pharmaceutical Patient Assistance Programs. Manage, train and mentor regulatory associates and/or quality specialists.

Milwaukee, Wi, Us

Assisted external and internal clients with Regulatory projects and compliance matters. Assisted external clients with Regulatory submissions including 510(k)s, PMA supplements, Pre-Submissions, Investigational Device Exemption (IDE) applications, Annual Reports and Submission Issue Meetings. Researched, organized, and managed the change of name/ownership for ~200 state pharmacy and distributor licenses as a result of a merger. Additional projects included: managing complex regulatory aspects of projects, including complex applications submitted to various regulatory agencies; managing internal and external regulatory projects simultaneously under tight deadlines; authoring complex premarket regulatory strategies; and, tracking the status of multiple regulatory applications and responding to requests for additional information as necessary to ensure that projects were completed on time. Assumed role of deputy HIPAA Privacy Officer and responsible for day-to-day HIPAA compliance.

Milwaukee, Wi, Us

Assisted external clients with Regulatory projects and compliance matters. Projects included: managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies; effectively communicating to clients the most compliant and efficient regulatory pathway for their product(s); and, authoring premarket regulatory strategies.

Milwaukee, Wi, Us

Supported the Regulatory Affairs Department in a variety of tasks and responsibilities. Specifically, comparing the regulatory history of a client's products to the current FDA regulations and guidance as a part of a 510(k) assessment and remediation project. Tasks also included writing Standard Operating Procedures (SOP) for necessary Regulatory responsibilities, as well as the preparation and submission of Import for Export (IFE) notifications to FDA. Responsibilities included organizing and assisting in the preparation of Special and Traditional 510(k)s including predicate research, authoring the major 510(k) sections, and formatting and assembling the submission to CDRH.

Master’S Degree, Health Sciences In Regulatory Affairs

Certificate, Regulatory Affairs

Bachelors Of Science, Biomedical Sciences

Certificate, Biomedical Engineering