Regulatory Affairs Specialist
ABOUT THE ORGANIZATION Coltène is a global leader in the development, manufacture and sale of consumables and small-size equipment for dental treatment applications. The Dental Group offers a wide range of products, encompassing six segments – solutions for almost all dental treatments.
Highly-qualified and enthusiastic employees are the basis of our success. In order to support and encourage this foundation, we foster a positive and motivating work atmosphere, which facilitates professional and personal development. Coltene offers a competitive compensation and excellent benefits package, which includes Medical, Dental, Vision, Prescription Drug, Life & Disability Insurance, Generous PTO and Tuition Reimbursement programs as well as access to world class manufacturing and lab facilities. Come Join Our Team!
Coltene has an opening for a Regulatory Affairs Specialist to join our Regulatory team at our Cuyahoga Falls, Oh site location. The 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 soliciting assistance from more senior regulatory staff members and working under the direct supervision of the Director of Regulatory / R&D.
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 Design History Files (DHF), Device Master Records (DMR) 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.
Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
Participate as a QMS internal auditor to maintain ISO13485 compliance.
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.
Review, analyze and approve validations as appropriate.
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.
Complete special projects as assigned by the Director of Regulatory / R&D.
Adhere to and promote all organizational policies and procedures.
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.
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 or other technology field is required
1-3 years of progressive experience in regulatory affairs required
Appropriate combination of education and experience may also be acceptable
Prior knowledge of 21CFR 820, ISO13485, MDD and MDR QMS requirements preferred
Experience with medical device products preferred
Experience with EPA regulations preferred
Experience with 510(k) submissions 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
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) | Tuition Reimbursement Program
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.
EOE STATEMENT 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
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Job posted: 2021-07-24