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Associate Director - Regulatory Affairs

Company: Kforce
Location: San Diego
Posted on: September 16, 2020

Job Description:

Kforce has a client seeking an Associate Director - Regulatory Affairs in San Diego, CA.Summary:This role provides regulatory guidance and oversight to ensure compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. The Associate Director has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities. Responsibilities:

Develop strategies for device regulatory submissions to health authorities worldwide

Organize and compile device regulatory submissions and other correspondence to US and international regulatory agencies that may be considered moderately complex in support of pharmaceutical/medical device combination product in Phase I-III programs

Manage communications with CROs and provide guidance for completion of regulatory submissions

Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications; Develop expertise in electronic common technical document (eCTD) guidances and practices

Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained

Health Authority Interactions: Interact with key personnel in regulatory entities to ensure the review and approval of development plans, the timely resolution of issues, and the approval of applications

Internal Advisory Activities: Provide input and recommendations for device design and process verification and validation activities with Manufacturing, Engineering and Quality groups

Review and approve data and documentation required for medical device/pharmaceutical combination product regulatory submissions

Requirements Bachelor/Master's degree in Engineering or a related area required

A minimum of 8 years in regulatory affairs with a minimum of 5 years in medical devices

Medical device or combination product regulatory affairs experience required

Electromechanical device experience desired

Experience and knowledge of the relevant current requirements for medical device or combination product submissions to US FDA and prior interaction or exposure with other key regulatory authorities (e.g. Notified Bodies, EU competent authorities, APAC regulatory agencies, etc.)

Strong regulatory writing, design control and quality system knowledge required; Knowledge of submissions tools and processes desired

Technical proficiency, effective problem solving and critical thinking skills

Excellent oral and written communication, interpersonal and organizational skills; Attention to detail

Ability to consistently meet tight timelines and deadlines

Ability to interact effectively with management

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Know someone perfect for this role? Recommend your friends and make money when they're hired using our app, KFORCEconnect. The more you refer, the more you earn! Download the app today to Connect. Refer. Get Paid.

Kforce is a solutions firm that builds and manages expert teams in technology and finance & accounting. We deliver on our client's objectives by combining a global knowledge force with flexible delivery and an unmatched drive for excellence. Kforce not only serves as a trusted partner to our customers, providing next level insights and powerful results, but also offers many consultants comprehensive benefits including medical, dental, 401(K), life insurance and disability.

Kforce is a professional staffing services firm specializing in flexible and direct hire staffing in Technology and Finance & Accounting, engaging over 23,000 highly skilled professionals annually with more than 4,000 customers.

Keywords: Kforce, San Diego , Associate Director - Regulatory Affairs, Other , San Diego, California

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