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)