Associate Director, Regulatory Affairs

The AD, Regulatory Affairs 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
30+ days ago