Director of RA - New Ventures

September 27

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Description

• Prepare regulatory strategies for New Ventures projects to enable marketing approvals • Develop and manage content strategy for regulatory submissions, including clinical trial applications (i.e., IDEs, INDs), new marketing applications supplements, and variations • Build and maintain relationships within the Regulatory Affairs functional areas, Clinical Affairs, Quality, Operations, New Ventures, and Research and Development (R&D) groups • Manage products and change controls in compliance with regulations and company policies and procedures • Represent New Ventures Regulatory on teams such as product development, Clinical, Quality, Marketing, and Operations to negotiate, influence, and provide strategic advice. • Serve as liaison and strategic partner with the FDA • Manage assigned projects within assigned resources. • May supervise others • Seek expert advice and technical support as required for strategies and submissions • Prepare and manage regulatory applications, including new applications and amendments, renewals annual reports, supplements, and variations • Review and revise regulatory submissions to effectively present data and strategy to regulatory agencies • Regularly inform regulatory management of important timely issues • Train, develop, and mentor individuals; this may include formal supervisory responsibilities • Develop and implement policies and procedures within the regulatory affairs department • Analyze legislation, regulation, and guidance, provide analysis to the organization • Support combination products and medical devices including design control and change management activities • Provide regulatory guidance and support for risk management and human factors engineering topics for drug, biologics, device, and combination products

Requirements

• A BS degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering, or a related subject • At least 10 years’ experience in regulatory affairs. • 5 years of pharmaceutical experience (with medical device/combination product developing and implementing successful global regulatory strategies is preferred • Experience with communication with health authorities (e.g., FDA, Health Canada) • The ability to operate in a fast developing and changing environment, able to differentiate and prioritize between multiple competing options, without losing sight of the long-term strategic objectives of the company • Experience with regulatory submissions for novel devices • Experience with regulatory submissions for Class II and III medical devices