Lead Regulatory Affairs Specialist

COLTENE is a global leader in the development, manufacture and sale of consumables and small equipment for dental treatment applications. COLTENE operates production facilities in Switzerland, Germany,Canada, France and the USA, as well as a worldwide sales network with its own representatives and distribution partners. Dentists and dental technicians worldwide rely on COLTENE products, both for conventional, as well as implant-based treatment and dental reconstruction.

We are looking for the Lead Regulatory Affairs Specialist to join our Regulatory department at the Cuyahoga Falls, OH location. The Lead Regulatory Affairs Specialist shall support the product portfolio, manufacturing operations, customer needs and P & L objectives of COLTENE by contributing to all phases of the product lifecycle as required. This includes providing regulatory guidance, registering products, evaluating engineering changes with respect to regulatory compliance, maintaining required regulatory records and reports and interacting with regulatory agencies and notified bodies.

This individual will be expected to utilize semi-advanced knowledge of the regulatory environment and business principles while working under the direct supervision of the Director of Regulatory / Quality.

Duties and responsibilities

• Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
• Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
• Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.
• Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.
• Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.
• Provide guidance to the Engineering staff on the creation and maintenance of Medical Device Files and Technical Files.
• Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.
• Analyze complaints regularly for trends to determine improvements to Design and Safety.
• Evaluate adverse event complaints that may need reported to applicable agencies and for post market surveillance activities, including clinical evaluation.
• Draft and maintain documentation related to post market surveillance activities, including clinical evaluation activities and post-market clinical follow up activities
• Review and approve labeling, IFUs and business literature.
• Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
• Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
• Provide assistance interdepartmentally in the formal assessment of risk in accordance to published regulations and/or customer expectations.
• Strive for continuous improvements to the regulatory processes.
• Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.
• Effectively lead projects or teams.
• Complete special projects as assigned by the Director of Regulatory / Quality.
• Adhere to and promote all organizational policies and procedures.
• Drive completion of projects independently.
• Demonstrate leadership ability on project teams.
• Provide leadership and guidance to less experienced team members.
• Provide innovation solutions to daily issues.

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.

Qualifications

The minimum qualifications listed below are representative of the knowledge, skill and/or ability needed in order to successfully perform the job.

• Bachelor’s degree in a science, mathematics, engineering, other technology field, or a law degree is required
• 7+ years of industry experience
• 3+ years of progressive experience in the field, including leading projects
• Appropriate combination of education and experience may also be acceptable
• Prior knowledge of 21
  
  CFR 820, ISO
  13485 and MDR QMS requirements required
• Experience with medical device products required
• Experience with MDSAP country requirements preferred
• Knowledge of pesticide regulations preferred
• ASQ, Six Sigma, RAPS or other regulatory certifications preferred
• Problem solving/analysis including statistical process control
• Technical capacity including decision making, communication and reporting
• Strong interpersonal communication skill set
• Organizational…