Manager or Director of Regulatory Affairs, Medical Devices, is responsible for leading various operational aspects of Medical Device Regulatory Affairs objectives for assigned devices and device/drug products, life cycle management initiatives and global regulatory strategy, regulatory submissions, and interaction with US and foreign regulatory authorities.
Key Responsibilities Include:
Responsible for developing and executing regulatory plans for assigned medical device programs.
Develops technical content, format, and accountability for regulatory submissions and related supplements and amendments.
Advises project teams regarding the development and implementation of regulatory strategy through the analytic, GMP and clinical development processes.
Establishes and maintains excellent relationships with regulatory agency personnel.
Responds to requests for additional data, organizes and manages participation in meetings.
Negotiates directly with regulatory authorities regarding company's filings.
Reviews and approves technical data and verifies accuracy of clinical data and execution of preclinical and clinical projects to regulatory authorities.
Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact and new guidances.
Reviews all external materials for regulatory compliance.
Serve as overall global regulatory lead accountable for all regulatory aspects of assigned projects, including development and implementation of the global regulatory development plan for the project.
Manages resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
Advanced education (e.g., MS, PhD, MBA, MD, Engineer, or microbiology with regulatory experience) highly preferred. Certified regulatory group membership (RAC) preferred.
Management and leadership experience at project level, experience with strategic initiatives/issues.
5-10 years medical device regulatory affairs experience.
Strong knowledge of current US and EU regulations.
Experience with developing and implementing regulatory strategies.
Solid understanding of requirements for 510 (k), PMA, CTA, Design Master File, ISO 13485 and 21 CFR 820. Hands on experience with writing 510(k) package, de novo, PMA, pre-submission meeting package, and participation in the FDA meeting.
Ability to strategically interpret and respond to requests from regulatory agencies.
Demonstrated track record in securing product clearances and approvals and maintaining a complex portfolio.
Proven leadership skills in a cross-functional team environment. International regulatory (ex-US) experience a plus.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
Oversight and/or guidance for required product testing.
Experience conducting vendor audits.
Ability to interact externally and internally to support global business strategy.
Must possess excellent oral and written communication skills. Given document intensive nature of the position, computer literacy with Word and Excel are required.
Must possess knowledge and experience with FDA and EMA electronic authoring, global standards from ICH, GHTF (through IMDRF), WHO and ISO.
Knowledge of and experience with FDA website registration and submission of documents.
Unique Device (UDI) registration experience a plus.
CSSi LifeSciences is a global, innovative CRO and consulting group that specializes in advancing drugs and medical device technologies from discovery to commercialization. We offer customized solutions to propel life science technologies to market by mitigating risks, time and cost, while increasing our clients success. We provide a fully integrated one-stop shop for medical device technologies from inception and “back of a napkin” ideation to commercialization. Our integrated model provides optimum value-creation for early-stage and emerging growth companies.