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Job #03666

About our client Our client is a young venture-backed bio-sciences company headquartered in Georgia that is focused on the development and commercialization of innovative medical devices. The company has multiple products on the market that are rapidly gaining momentum due to ground-breaking efficacy and a diverse range of applications. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Vice President of Regulatory Affairs Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Work closely with the Senior Corporate Leadership Team 2) Plan, compile, authorize, review, interpret and distribute quality regulatory submissions to meet Health Authority (HA) commitments and corporate goals 3) Maintain compliance with corporate, divisional and HA policies/procedures and regulations 4) Evaluate regulatory risks for various strategies and make recommendations to the management 5) Influence the adoption of identified regulatory strategies while remaining current on new developments 6) Work with both internal and external personnel to provide technical support to ensure the advancement of the R&D pipeline 7) Transfer products from R&D to production and to support ongoing production operations 8) Enforce practices to ensure the company remains in compliance at all times 9) Provide regular and timely feedback to the President/CEO and designated corporate management staff on a variety of topics, including status of the worldwide regulatory and quality programs, recruiting/hiring, vendor and contract agency evaluations, etc. 10) Develop regulatory strategies, with risk assessments and updates, that meet overall corporate and specific product and worldwide market introduction goals, and are proactive and responsive to changes in company plans and governmental requirements 11) Plan and conduct formal meetings and teleconferences with regulatory authorities to facilitate the review and approval of marketing applications with high-level management and worldwide regulatory authorities 12) Implement quality systems and strategies for specific products, projects and existing products and facilities to expedite and facilitate regulatory filing, review and approval, to protect continued marketing of existing products and to meet or exceed customer expectations 13) Establish technical testing requirements at the developmental stage to determine candidate product’s feasibility and develop the project plans to achieve developmental objectives and goals 14) Develop study protocols, ensure that preclinical and clinical investigations are conducted in accordance with applicable regulations, within and outside US 15) Negotiate agreements with physicians to provide timely, cost-effective and conclusive safety and efficacy data 16) Develop effective regulatory filings that result in product approvals that meet product and market introduction goals and result in the protection of continued marketing 17) Ensure that all appropriate registrations, certifications, dossier and technical file updates, listings, licenses and other regulatory documents are obtained and current to allow marketing and distribution of products in all intended worldwide markets 18) Develop and implement quality inspections for all appropriate manufacturing stages and steps to ensure that all products released for distribution meet or exceed established specifications and customer expectations 19) Review, approve and provide guidance for products labeling and marketing advertising in all media formats to ensure compliance with applicable FDA, FTC and worldwide laws and regulations 20) Develop critical quality indicators to monitor and identify potential problems and for continuous improvement 21) Provide regulatory and quality support to project teams to ensure risk management and design controls are applied and their timely and successful completion 22) Perform duties of the “Management Representative” and represent the company before regulatory agencies, certification bodies 23) Conduct management reviews with top management to report and discuss the adequacy and effectiveness of the company’s quality system and to identify any need for improvement 24) Maintain awareness of all regulatory approval and compliance requirements 25) Inform senior management of potential regulatory, compliance or quality risks and necessary corrective actions 26) Ensure the promotion of awareness of current regulatory, quality and compliance requirements throughout the organization 27) Provide regulatory requirements training and facilitate the transfer of knowledge to company employees 28) Form strong alliances with peers and externally with strategic partners for the purpose of completing departmental and company objectives 29) Develop the annual budget for regulatory affairs and quality assurance 30) Ensure all appropriate certifications, licenses and registrations are obtained in order to design, evaluate, manufacture and distribute products in all intended markets worldwide 31) Lead the review, analysis and guidance of failure investigations and corrective actions referred to regulatory affairs 32) Perform other duties as assigned by Management Requirements 1) Experience in planning, compiling, authoring, reviewing, interpreting and distributing quality regulatory submissions to meet Health Authority (HA) commitments and corporate goals 2) Experience in 510k submissions with both domestic and international regulatory affairs experience 3) Ability to influence the adoption of identified regulatory strategies while remaining current on new developments, department recruiting and hiring, vendor and contract agency evaluations, annual budget development and management 4) Proven track record in leading worldwide regulatory and quality programs 5) Proven track record in implementing quality systems and strategies for new products, projects and existing products and facilities to expedite and facilitate regulatory filing, review and approval, to protect continued marketing of existing products and to meet or exceed customer expectations 6) Knowledge of medical device requirements and enforcement practices