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