At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

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

• 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

• 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

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Occasional travel required

• 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

• 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

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (12 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.