Coltene has an opening for a Sr. Regulatory Affairs Specialist to join our Regulatory team at our Cuyahoga Falls, Oh site location.
The Senior 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 Quality / Regulatory Manager. We are looking for a local candidate, relocation is not provided for this role. Hybrid schedule is available after training is completed (2 days remote, 3 days onsite).
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.
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.
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 Quality / Regulatory Manager.
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.
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 or other technology field is preferred
5+ years of progressive experience in regulatory affairs required
Appropriate combination of education and experience may also be acceptable
Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements preferred
Experience with medical device products preferred
Experience with EPA regulations preferred
Experience with EU MDR Technical Documentation preferred
Experience with 510(k) submissions preferred
Experience with Health Canada Licence submissions and amendments preferred
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
Working conditions:
While performing the duties of this job, the employee works in both an office and plant environment. The noise level in the work environment is quiet to moderate. This is a full-time exempt position requiring at least 40 hours per week, with hours of work and days scheduled determined by the Quality / Regulatory Manager. Special circumstances such as off shift and weekend work might occur on rare occasions. This position requires minimal travel. Some of the travel may be international.
Physical requirements:
While performing the duties of this job, the employee spends time sitting at a desk, however the employee is frequently required to stand for periods of time and walk out to the manufacturing area to work on projects. Prolonged periods of concentration and focus are required along with an outgoing personality and the ability to deal with stress of time constraints. The employee is occasionally required to use hands and fingers to handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear. When not required to travel away from the facility, this position requires regular and consistent attendance at the facility.
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) | Tuition Reimbursement Program | Pet Insurance | LinkedIn Learning subscription | Volunteer Time Off | Wellness Reimbursement
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