Regulatory Affairs Specialist

LifeNet Health•Virginia Beach, VA

12d•$65,972 - $87,962•Onsite

About The Position

As a Regulatory Affairs Specialist, you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for supporting the organization’s compliance with global regulatory requirements within the medical device, biologics, and tissue combination product industry. This role is responsible for monitoring and maintaining documentation of applicable laws and regulations; supporting the development and execution of regulatory strategies for new products and market expansions; preparing and submitting of dossiers for regulatory approval; evaluating change requests for impact on regulatory submissions; reviewing product labeling and promotional materials to ensure regulatory compliance; and responding to internal and external requests for regulatory information. Your work will have purpose every single day, contributing directly to life-changing outcomes.

Requirements

Bachelor’s Degree
THREE (3) Years – Regulatory experience in medical device or similar regulated industry
Technical Writing: Applies plain-language principles and structured writing techniques to present technical information clearly and accurately to both technical and non-technical audiences.
Time Management: Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependences and potential risks/pitfalls.
Communication Skills: Excellent communication skills; ability to communicate and build relationships with all professionals at different levels within the organization
Attention to Detail: Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
Teamwork: Ability to mentor junior staff and lead team. Ability to be collaborative and work as part of a team to resolve issues, complete tasks, and meet business needs.
Proficient in MS Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite, as position requires

Nice To Haves

Bachelor’s Degree – Engineering, Chemistry, Biology, Regulatory Affairs or other science-related discipline
RAPS – Regulatory Affairs Certification
FIVE (5) Years – Regulatory experience in medical device or similar regulated industry

Responsibilities

Plans, organizes, and submits dossiers for regulatory approval.
Evaluates the potential impact on submissions from new guidance and regulations.
Tracks the status of applications under regulatory review and provides updates to management and applicable stakeholders.
Coordinates the development of timely responses to regulatory authorities’ queries and leads interactions with regulatory authorities during the review process.
Provides regulatory input and guidance on global regulatory requirements to product development teams.
Evaluates product classifications and submission pathways across global markets, develops and implements regulatory filing strategies, and communicates key submission milestones and status updates.
Serves as regulatory lead on cross-functional product development teams.
Reviews and provides feedback on documentation for design review, evaluates technical documentation for regulatory submissions to ensure compliance with applicable regulations and standards, and collaborates with the product development team to address regulatory authority’s queries, deficiencies, and submission-related requirements.
Participates in the review of change requests to determine the impact on regulatory submissions.
Communicates submission filing status and relevant milestones.
Prepares and submits post-market change notifications to applicable regulatory authorities and/or external partners.
Research jurisdictional requirements and options for regulatory submissions, approval pathways, and compliance activities.
Maintains regulatory documentation, assisting with regulatory submissions, registrations, licenses, and listing.
Partners with Regulatory and Quality teams to evaluate the impact of regulatory changes, support the development and implementation of regulatory procedures, and ensure product labeling and promotional materials comply with applicable regulations and guidance.
Maintains regulatory information within internal systems and regulatory authority databases and prepares regulatory documentation and certifications to support internal and external requests.