Regulatory Affairs Specialist

3 days ago

Cuyahoga Falls, United States COLTENE USA Full time

The Regulatory Affairs Specialist – Labeling Specialist is responsible for developing, revising and implementing new and revised labeling for both medical device products and pesticide products. The Labeling Specialist shall coordinate all labeling activities and translations and shall support Coltene by ensuring all product labeling is accurate and compliant. This responsibilities for this function include providing regulatory guidance, revising / updating labeling, creating engineering change notices, and reviewing engineering changes with respect to labeling updates and changes. This individual will be expected to remain current with regulatory requirements for labeling in all applicable markets throughout the world, which includes but not limited to United States, Canada, the European Union, United Kingdom, Switzerland, Brazil, China, Australia, Japan, Thailand and Taiwan. In addition, this person will ensure compliance to applicable EPA regulations. This person will work closely with Engineering, Regulatory, Product Management, Supply Chain, Manufacturing and Quality and will work under the direct supervision of the Director of Regulatory / R&D.



Duties and responsibilities


  • Coordinate the label revision process for medical devices and pesticide products.
  • Develops, revises and reviews product labeling to assure compliance to Regulatory requirements.
  • Works with R&D, Product Management, Quality, Supply Chain and Graphics to ensure specifications are accurate.
  • Remain current in Regulatory requirements for medical device labeling and pesticide labeling.
  • Support New Product Development in the creation of new labels.
  • Support Manufacturing in labeling issues that arise.
  • Create engineering change notices.
  • Work with Supply Chain to ensure label stock is managed during label changes.
  • Assist in establishing and maintaining labeling systems to ensure continuous medical device and environmental regulatory compliance.
  • 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.



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
  • Knowledge of 21CFR 820, 21 CFR 801, 40 CFR 156, MDR Labeling Requirements, ISO13485 requirements preferred
  • Experience with medical device products is preferred
  • Proficient in Microsoft Office Suite (Word, Excel, Project, Power Point, Outlook)
  • Project management experience preferred
  • Ability to prioritize multiple projects
  • Excellent follow-up skills
  • Attention to detail
  • Problem solving
  • 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 Director of Regulatory / R&D. 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. The employee must occasionally lift and/or move up to 50 pounds. 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


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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