Director of Regulatory Affairs - PRRC

International Regulatory Affairs Specialist

Under general supervision, is responsible for assisting in the development and maintenance of international regulatory submissions, systems and processes to support the identification, preparation, organization and classification of all documents utilized for obtaining global medical device regulatory clearances as required to import, market and distribute and maintain products in international markets. This role will also contribute by monitoring and analyzing regulatory trends and positions of industry within the consumer and medical divisions.

This role will be responsible for assisting in the execution of defined regulatory strategies. This individual is responsible for liaising with other departments, external consultants and regulatory team to ensure registrations, GSPRs, conformity assessments and other relevant documentation are accurate and up-to-date. This role will also sit on assigned project teams to provide regulatory guidance and disseminate regulatory information, as needed.

Key Duties and Responsibilities:

• Ensures compliance with regulatory requirements and internal procedures.
• Provides guidance on regulatory requirements and strategies to project teams.
• Assists in regulatory matters involving the US FDA and other government agencies, as directed.
• Communicate regulatory requirements throughout the organization as appropriate
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners according to the defined regulatory submission strategy.
• Timely compile materials for license renewals, updates and registrations
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies and partners.
• Maintain current knowledge of FDA and international regulations, guidance, and standards applicable to company products.
• Oversee the fulfillment of general safety and performance requirements, conformity assessments, compliance with labeling and distributor/importer requirements.
• Lead regulatory intelligence efforts and participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC and R&D department and senior management as required.
• May perform other duties as required

Qualifications, Education and/or Experience Required:

• Minimum BA/BS degree in scientific or legal discipline
• 10-15 years' experience in Regulatory
• Understanding of the European Medical Device Regulations (MDR) or ability to quickly learn requirements
• Understanding of the Medical Device Single Audit Program (MDSAP) or ability to quickly learn requirements
• Experience with chemical or product registration/notification in different applicable areas, preferably for Medical, Electronics and/or Cosmetics applications.
• Audit experience preferable. (ISO, EU MDR, MDSAP)
• Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels.
• Exhibits a high degree of integrity, initiative and motivation.
• Strong ethics and regulatory compliance awareness
• Attention to detail and ability to manage multiple tasks
• Capacity to work independently, with excellent time management and judgment in task prioritization
• Able to interact with multiple individuals in a positive, constructive manner and under a variety of circumstances.
• Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders.
• Capability to understand technical information/science as it applies to products, and the ability to translate into a business context.
• Excellent English verbal and written communication skills
• 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.
• Sitting, walking, standing for prolonged periods. Driving short distances.

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.