Regulatory Affairs Manager

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Job description

Responsibilities:

Provides regulatory leadership to assigned platform teams providing regulatory guidance throughout the product development lifecycle and coordinating team inputs for regulatory submissions.

Works with Associate Director and Platform Leaders to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans

Foster deep regulatory partnership and drive execution of critical customer initiatives

Takes lead regulatory role for new customer engagement with commercial leaders

Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers' regulatory submissions.

Takes a lead role in key business decisions and plan regulatory resources accordingly to ensure the development of an efficient organization and continuously seek for improvements in efficiency.

Identifies and communicates potential risks and mitigations associated with regulatory strategies to partners.

Support to customers for regulatory advice and registration of their products and interact as necessary with the U.S. regulatory agencies and Notified Bodies.

Reviews and/or approves product marketing claims and communication, promotional materials, labelling, clinical protocols and clinical reports.

Conducts training on regulatory issues for staff and for business partners (e.g., Platform, R&D, Marketing and Pharma Partners).

Participates in internal/external trade, professional, and standards development organizations.

Manages multiple projects with minimal supervision.

Requirements:

B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.

Minimum five 5 years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields.

Demonstrated project management, negotiation, and communication (written and oral) skills.

Working knowledge of regulations for medical devices and drug-device combination products.

Understanding of product development cycle, clinical phases, change management and marketing of pharmaceutical products.

Experience with software and digitally connected devices.

Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators.

Ability to resolve problems and to make appropriate regulatory decisions under pressure.

Ability to adapt and respond quickly in a constantly evolving and often ambiguous environment.

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