Summary:

Under general supervision, is responsible for the overall organization, planning and up-keep of clinical regulatory activities and initiatives. Draft and maintains documents for clinical investigations and evaluations globally. Oversees clinical trial activities. Stays abreast of global clinical trial requirements. Liaises with R&D, Marketing/Sales and other key stakeholders on the development of clinical trial strategies in support of product development and/or sustainability.

 Key Duties and Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Liaise with Marketing, R&D, Quality and other key stakeholders in short-term and long-term planning of clinical  initiatives in support of submissions in Canada, EU and Emerging Markets, including, but not limited to, Asia-Pacific, South America, Middle East and Africa.

• Assists regulatory team in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the clinical trial duration for research studies involving human subjects.
• Write clinical evaluation plans, reports, and clinical investigation documents in accordance with the clinical evaluation process and applicable regulatory standards (EU MDR, MEDDEV and ISO)
• Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.

• Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
• Assist in the development and maintenance of risk management files and other associated documentation in accordance with the requirements of ISO 14971 and other global requirements and/or standards.
• Provide medical expertise in the review of safety information and adverse events for investigational and marketed product, including evaluating case reportability per local regulatory requirements and meeting appropriate timelines for case review.
• Review and summarize scientific literature relevant to pharmacovigilance in the development of clinical evaluation and periodic safety reports (e.g. PSUR, etc.) in accordance with international requirements and guidelines.
• Support in the development of claims/advertising and promotional material that adheres to regulations, ensuring risks are appropriately addressed and communicated.
• Stay up-to-date, interpret and distribute information, to key stakeholders, on current, future and proposed international regulations, standards, or guidance documents, as needed

Qualifications, Education and/or Experience Required:

• Bachelor's degree or equivalent combination of education and experience in a scientific or healthcare discipline
• 3+ years of experience in clinical laboratory or clinical research/product development; experience in a medical device/IVD company is a plus.
• Knowledge in EU Medical Device Regulations 2017/745 

Language Skills:

• English required, bilingual (Spanish) a plus.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Work Environment:

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 

AAP/EEO Statement

CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

• Bachelor's degree or equivalent combination of education and experience in a scientific or healthcare discipline
• 3+ years of experience in clinical laboratory or clinical research/product development; experience in a medical device/IVD company is a plus.
• Knowledge in EU Medical Device Regulations 2017/745