Associate Director, Regulatory Affairs - North Carolina, United States - BioAgilytix

BioAgilytix North Carolina, United States

2 weeks ago

Description

The Regulatory Affairs AD is in charge of managing regulatory tasks for projects involving new products and product life cycle management. This includes creating and executing regulatory strategies and timelines, as well as preparing submissions.

Key Responsibilities:

Guiding product core teams to ensure regulatory submissions are planned, communicated, and executed according to requirements
Providing regulatory insight for complex issues related to registration and compliance
Interpreting and communicating FDA/international regulations to ensure accurate product submissions
Preparing submission reports, technical files, and clinical trial applications for regulatory agencies
Coordinating resolution of regulatory issues with internal resources and regulatory agencies
Reviewing post-market product changes and determining appropriate change control mechanisms
Advising on regulatory impact, ensuring compliance, and acting as a liaison with regulatory bodies
Assisting in updating internal policies and procedures
Supporting regulatory compliance through audits, customer complaints, and training
Providing training and materials to enhance team's regulatory knowledge
Other duties as assigned

Minimum Preferred Qualifications: Education/Experience

Bachelor's degree in biology, chemistry, or a related field
At least eight (8) years of experience in pharmaceutical or related industries

Minimum Preferred Qualifications: Skills

Proficient in IDE/IVDR requirements
Knowledgeable in cGMP, ISO 13485, FDA, and EU Medical Device requirements
Experience with CE Mark certifications
Strong project coordination and management skills
Ability to work independently and achieve results in a fast-paced environment
Excellent communication and interpersonal skills
Proficiency in Microsoft Office and strong computer skills
Detail-oriented with strong organizational skills

Working Environment

Office-based role
Uses standard office equipment and may require occasional travel

Physical Demands

Ability to work upright for extended periods
Repetitive hand movements for operating office equipment
Occasional mobility, bending, and lifting up to 20 pounds
Ability to use various computer software
Effective communication and interaction with others
Works independently with focus and adaptability
Performs various tasks under changing conditions
Ability to handle stress and multitask
Regular attendance is essential

Position Type and Expected Hours of Work

Full-time role with flexibility in work hours
Availability during core work hours and occasional weekend/evening work

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