Senior Regulatory Affairs Specialist

MillenniumSoft Inc · Franklin Lakes, NJ · 23 mo ago

LegalContract

About the role

This is an excellent contract to hire opportunity to gain hands-on experience in the regulatory field with business-to-business customer exposure, global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management.

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
Maintain compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Perform regulatory impact assessment of changes related to design, improvements and customer experience and coordinate supplement/notification/change submissions for timely implementation
Collaborate with multiple stakeholders including 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
Manage 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 processes and best practices as necessary

Requirements

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

Able to drive and maintain favorable customer experience and customer-centricity (internal & external)

No remote position. Associate must be available onsite.

BD provides Flexible policy

Qualifications

B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred.

Skills

Strong project management and communication (verbal, written) and skills