2024-05-15
AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Durham
North Carolina
27703
United States
The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.
Essential Responsibilities
Provides guidance to product core teams to ensure that all regulatory submissions are planned, communicated, and executed per regulatory and business requirements
Provides regulatory opinion for complex or unique issues and challenges regarding registration and compliance activities
Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions
Prepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agencies
Coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed
Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission)
Advise on impact of regulations, devises strategies for compliance and acts as liaison with regulatory bodies and sponsors for facility inspections, licensure and permits
Assist in the update, enhancement, and creation of internal policies and procedures
Supports regulatory compliance to ISO, FDA, and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems
Conduct trainings and/or communicate appropriate materials, as needed, to enhance team's knowledge of working in a regulated environment
Other duties as assigned
Minimum Preferred Qualifications: Education/Experience
Bachelor's degree in biology, chemistry, or other scientific or related discipline
Not less than eight (8) years of experience in pharmaceutical, CRO/CMO, or similar organization
Minimum Preferred Qualifications: Skills
Strong, working knowledge of IDE/IVDR requirements
Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and (New) EU Medical Device requirements
CE Mark product certifications experience
Demonstrated project coordination and management skills; strong experience in a QMS function
Ability to achieve results and function independently in a fast-paced environment; ability to self-motivate with strong work ethic
Excellent oral and written communication skills
Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders
Strong computer skills, including proficiency in Microsoft Office (e.g., Outlook, Word, Excel)
Ability to take direction well and multi-task
Acute attention to detail and organizational skills
Working Environment
Primarily office
Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Occasional travel required
Physical Demands
Ability to work in an upright and/or stationary position for up to eight (8) hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
Occasional mobility needed
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moving) objects, including files and laptop computer, with a maximum lift of 20 pounds
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance
Position Type and Expected Hours of Work
This is a full-time position
Some flexibility in hours is allowed, but the employee must be available during the "core" work hours
Occasional weekend, holiday, and evening work required
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