Senior Regulatory Affairs Specialist - Urgent Need
Company: millenniumsoft
Location: Franklin Lakes
Posted on: April 1, 2026
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Job Description:
Position : Senior Regulatory Affairs Specialist Location :
Franklin Lakes, NJ Duration : 12 Months Total Hours/week : 40.00 1
st Shift Client: Medical Devices Company Job Category: Regulatory
Affairs / Compliance Level Of Experience: Senior Level Employment
Type: Contract on W2 (Need US Citizens Or GC Holders Only) Job
Description: New RA position dedicated to the Reusable Pen Platform
and its 2 strategic customers with client for Pen and Pen needles
registered in over 80 countries. This is an excellent contract to
hire opportunity to gain hands of experience in regulatory field
with Business-to-Business customer exposure, global submission
activity, regulatory intelligence reviews, health authority
interactions/audits, and project management. General Function :
Drive Global implementation and customer deliverables for Reusable
Pen platform per PS RA team Strategy Main Responsibilities: Ensure
timely execution of regulatory strategies and customer deliverables
as determined by RA Manager Manage and execute end to end
activities, such as documentations, submissions and addressing
health authority questions for new or renewal of existing medical
device registrations of Reusable Pen and pen needles in worldwide
market Maintenance of compliant regulatory files and supporting
documentation (EU technical files/ US master files/international
technical dossiers) in WW market Performs regulatory impact
assessment of changes related to design, improvements and customer
experience and coordination of supplement/notification/change
submissions for timely implementation Effective Collaboration with
multiple stakeholders i.e., internal teams (PS cross functional,
BDX), customers (consultants, pharma partners) and regulators (EU
Notified Body, Health Canada, FDA) for technical requirements and
documentation to support regulatory registrations, project
deliverables and audit ready folders Manages multiple projects with
attention to detail for health authority submissions and represent
RA in internal and external audits by customers and health
authorities for compliance to MDSAP, EUMDR, ISO 13485 and global
compliance Identify ways to improve the efficiency of current work
process and best practices, as necessary. Education: B.S. degree in
a technical discipline (e.g., pharmacy, engineering, biology,
chemistry). Advanced degree preferred. Experience: Minimum of 5
years of directly related work experience in medical device
regulatory field (regulatory submissions, compliance, project
management) Medical device and international registration
experience is a must. Combination Products knowledge or experience
is a plus. Proficient in using Microsoft Word, Access, Excel,
OneNote, Project, and OneDrive/SharePoint Interpersonal and Social
Skills: Strong project management and communication (verbal,
written) and skills Able to independently handle multiple
tasks/projects with minimum supervision Self-starter with the
ability to take over responsibilities Team player, Attention to
details, highly result-oriented Flexible and reliable personality;
ability to manage stressful situations High personal integrity and
ethical standards Ability to drive and maintain favourable customer
experience and customer-centricity (internal & external)
Keywords: millenniumsoft, Wayne , Senior Regulatory Affairs Specialist - Urgent Need, Healthcare , Franklin Lakes, New Jersey
