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 21CFR 820, ISO13485 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
Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
Problem solving/analysis including statistical process control
Technical capacity including decision making, communication and reporting
Strong interpersonal communication skill set
Organizational skills
Effectively work independently
Working conditions
While performing the duties of this job, the employee works in primarily an office environment. The noise level in the work environment is quiet to moderate. This is a full-time salary exempt position requiring at least 40 hours per week. Hybrid schedule is available which would include up to 2 remote days per week after completing 90 days of employment.
Direct reports
None
Benefits
Coltene offers a comprehensive employee benefit program that enables our employees to stay healthy, feel secure and maintain a work/life balance: Generous Paid Time Off | Holiday Pay | Medical/Prescription Insurance | Dental Insurance | Vision Insurance | Health Savings Account (HSA) | Company-Paid Life and AD&D Insurance | Company-Paid Long-term and Short-term Disability | Voluntary Life Insurance | Voluntary Critical Illness, Hospital and Accidental Injury Insurance | 401(k) with match | Pet Insurance
It is the policy of Coltene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Coltene will provide reasonable accommodations for qualified individuals with disabilities.
