Spec 3, Regulatory Affairs
Spec 3, Regulatory Affairs
Software Technology Inc.
Franklin Lakes, NJ
See who Software Technology Inc. has hired for this role
Location: Franklin Lakes NJ
Duration: 12 Months
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, clientX), 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 favorable customer experience and customer-centricity (internal & external)
Location: Franklin Lakes, New Jersey
No Remote position. Associate must be available onsite.
client provide Flexible policy
Why join us?
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components - is designed to support the varying needs of our diverse associates.
No Remote position. Hybrid model. Confirm Bill Rate: Not to exceed $$$/Hr
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Other -
Industries
Information Technology & Services
Referrals increase your chances of interviewing at Software Technology Inc. by 2x
See who you knowGet notified about new Regulatory Affairs Specialist jobs in Franklin Lakes, NJ.
Sign in to create job alertSimilar jobs
People also viewed
-
Regulatory Affairs Supervisor - (Regulatory)
Regulatory Affairs Supervisor - (Regulatory)
-
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
-
Regulatory Affairs Specialist
Regulatory Affairs Specialist
-
Associate, Regulatory and Government Affairs
Associate, Regulatory and Government Affairs
-
Manager Regulatory Affairs
Manager Regulatory Affairs
-
International Regulatory Specialist
International Regulatory Specialist
-
Senior Regulatory Affairs Specialist - Urgent Need
Senior Regulatory Affairs Specialist - Urgent Need
-
Looking for Senior Regulatory Affairs Specialist - Franklin Lakes, NJ [No Remote position. Hybrid model]
Looking for Senior Regulatory Affairs Specialist - Franklin Lakes, NJ [No Remote position. Hybrid model]
-
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
-
Corporate and Regulatory Affairs Specialist
Corporate and Regulatory Affairs Specialist
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More