3 Staff Regulatory Affairs Specialist Jobs near me
Software Technology Inc is Hiring a Staff Regulatory Affairs Specialist Near Franklin, NJ
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
- 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)
- 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.
Job Summary
Full Time
IT Outsourcing & Consulting
$91k-118k (estimate)
06/05/2024
07/02/2024
stg-corp.com
MIAMI, FL
25 - 50
Private
NILDA F RAMOS
$5M - $10M
IT Outsourcing & Consulting
Related Companies
The job skills required for Staff Regulatory Affairs Specialist include Regulatory Affairs, Product Development, Planning, Chemistry, Leadership, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Staff Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Staff Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
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