client is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Staff Regulatory Affairs Specialist will work in client Medical - Pharmaceutical Systems Business Unit taking on a lead design core team member role representing the RA function for novel drug delivery device and combination product development. The incumbent will plan and execute regulatory strategies for the US, EU, and international markets. The ideal candidate will have deep medical device experience in the US and EU along with successful submissions. New product development and/or drug-device combination product experience will be a plus.
Key Responsibilities Will Include
Works with RA Manager and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer results
Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers' regulatory submissions
Partners with and supports Pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals
Performs regulatory impact assessment of changes linked to the field of expertise and assigned platform
Liaises with cross-functional and cross company teams to meet customer needs in driving new drug delivery solutions for global markets
Develops and maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners
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 EU Notified Bodies
Reviews and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling
Conduct trainings on regulatory issues for staff and for business stakeholders (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
About You
To be successful in this role, you require:
Knowledge in medical devices regulation registration requirements and pathways (variations, renewals, supplements), in the US and EU markets. Pharmaceutical experience is a plus.
Understanding of product development cycle and quality management systems
Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators
Ability to use your time productively and efficiently (structured and self-organized with strong project management skills)
Ability to resolve problems and to make appropriate regulatory decisions under pressure
Ability to adapt, multitask and respond quickly in a rapidly changing and often ambiguous environment, Strong team player.
Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)
Education And Experience Required
B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields
Demonstrated project management, negotiation, influencing and communication skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Information Technology & Services
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