Regulatory Affairs Specialist

Summary:

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 organizing, filing and keeping regulatory documentation up to date in both the Performance Materials and Medical divisions. This individual is responsible for liaising with other departments, external consultants and regulatory team to ensure technical files, registrations, certifications, declaration of conformities, SDSs and other relevant documentation are accurate and up-to-date. Title will be dependent upon experience.

Key Duties and Responsibilities:

• Lead Product Stewardship reviews and documentation activities for R&D programs, as well as legacy products/product lines.
• Participate in new chemical assessments (R&D and commercialization), new product, product transfer, and change reviews
• Expand expertise and knowledge in EU MDR regulations to fulfill general safety and performance requirements, compile technical files, assist teams in compliance with labeling and distributor/importer requirements and manage the completion of conformity assessments.
• Help to define and implement business Product Stewardship & Regulatory Managing Systems and associated processes as needed
• Respond to internal/external customer inquiries regarding product regulatory or product stewardship issues
• Collaborate with business and other functional team members in all regions as appropriate
• Coordinate and maintain internal regulatory management records, import/export documentations, certificates/permits for product/chemical registration/notification to support regulatory compliance or customs clearance.
• Generate and ensure all regulatory reports (such as SDS/Labels) are in compliance with local regulatory requirements.
• Support internal and external audits in line with the audit plan through the preparation and organization documentation and records.
• Stay up-to-date, and distribute information, to key stakeholders, on current, future and proposed international regulations, standards, or guidance documents, as needed.
• Other duties as required.

Qualifications, Education, and/or Experience Required:

• BS/MS in Science with demonstrated in-depth understanding of those principles in a related field.
• 1-3 years medical device business or industry regulatory experience, 3-5 years preferred
• 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.
• Reasonable accommodations can be made, up to and including translation services.

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:

• Non-temperature-controlled warehouse, non-temperature-controlled production floor, temperature-controlled office.
• 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.