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Regulatory Affairs Manager (Medical Device)

Company: Rincon Search Group
Location: Orange
Posted on: March 28, 2020

Job Description:

**RA Submission experence required****Relocation assistance to Orange County CA offered (post COVID-19)****Remote based interviewing and onboarding**Rincon Search Group is executing an RA Manager search on behalf of one of our industry leading Orange County based Medical Device cleints. Our rapidly growing client has developed cutting-edge class II/III medical devices accross multiple therapeutic areas. Please see the positon description below:POSITION DESCRIPTIONThe Regulatory Affairs Manager is responsible for worldwide product approval submission activities and regulatory compliance for products.--This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs.--Collaborate with R&D, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.--Manages department activities with responsibility for results in terms of costs, methods and employees.--Accomplishes results through hands on and delegation of responsibility to individual contributors.--Provides leadership, coaching and career development.--POSITION RESPONSIBILITIESLead a team of 6+ experienced RA ProfessionalsProvides direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems. Develops and administers budgets, schedules, and performance standards. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.Develop global regulatory strategies for medical device, pharmaceutical, and combination product to meet business objectives.Participate on Product Development teams, providing regulatory strategies, timelines, and direction.--Reviews and approves technical documentation.Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.Drive product change assessments and define regulatory impact of product changes in global markets.Review and approve labeling, training, promotional, and advertising material.Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Company, U.S. FDA, and international requirements.Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.Participate on audit and field action teams.Sponsor and actively monitor a performance management culture where employees have clear performance expectations.Provide targeted career coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.Conduct timely and candid performance evaluations. Support meaningful development activities.BASIC QUALIFICATIONSEducation Required:------------------Bachelor's Degree required.--Engineering, Life Sciences and/or Advanced degree desired.Years of Experience:------------------5+ years of experience in the medical device industry with background in regulatory affairs------------------3+ years of leadership experience, preferably in regulatory affairsDESIRED/PREFERRED QUALIFICATIONSKnowledge of U.S. and European/International regulations and standardsExperience interacting with FDA and/or other regulatory agenciesProven ability to prioritize, conduct, and manage time to meet project deadlinesMust work well in dynamic and cross functional team environmentsMust demonstrate leadership skills in team settingProven analytical abilities

Keywords: Rincon Search Group, Orange , Regulatory Affairs Manager (Medical Device), Executive , Orange, California

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