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Summary:

Under general supervision, the Senior Regulatory Affairs Specialist is an expert in specific field of study responsible for liaising with other departments to lead efforts to update systems and processes in compliance with guidelines or regulations that govern Chemence Medical products.

The Senior Regulatory Affairs Specialist will also assist the organization in training, implementation and preparation for new or updated standards, guidance and regulations (e.g. 21 CFR 820, ISO 13485, EU MDR and MDSAP).

The Senior Regulatory Affairs Specialist will serve as the project lead for successful implementation of systems, processes and training programs.

Key Duties and Responsibilities:

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

• Implement new projects or programs at Chemence Medical to comply with newly implemented or changes to existing regulations.
• Assists with managing Global registrations and Economic Operators.
• Perform scientific and technical analyses on medical devices during early product development to assess compliance requirements.
• Updates PMS, GSPRs, PMCF and Essential Principal documents as needed.
• Assess changes to marketed devices, determine effects on regulatory global regulatory status, and perform resulting regulatory activities.
• Research regulatory and industry changes that may impact global regulatory operations and reports to teams for evaluation
• Prepare adverse event reports in accordance with applicable regulations
• Provides audit support during FDA, ISO and Notified Body Audits and Corporate
• May perform other duties as required

Qualifications, Education and/or Experience Required:

• Bachelor’s degree (or higher) in scientific or engineering discipline
• 8+ years of related industry experience
• Expert in specific guidance, standard or area (e.g. Auditing, EU MDR, Clinical Studies)
• Excellent English verbal and written communication skills
• Strong analytical and organizational skills with the ability to multi-task and prioritize competing demands
• Computer skills with proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat

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.