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Regulatory Affairs Manager

Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: January 13, 2022

Job Description:

The Regulatory Affairs Manager shall oversee regulatory affairs activities for Coltene including shared or co-sponsored regulatory activities with other divisions of the company. The primary responsibility of this position is management of regulatory systems including but not limited to those pertaining to ISO, FDA, Health Canada, EU, EPA, MHRA, ANVISA, TGA, MHLW and IEC/ UL/CSE to ensure process and product compliance. The individual will drive corporate policy and lead a staff of regulatory personnel to ensure that all pertinent systems and finished product meets regulatory standards. Adherence to domestic and international regulations and the dates for when they become effective will be of critical importance for all work performed. The Regulatory Affairs Manager will provide compliance leadership and technical expertise for the corporation. Active participation in consultation for product support, design control and continuous improvement is an expectation as well. Duties and responsibilities

  • Ensure that the regulatory systems and processes are maintained in compliance with both domestic and international regulatory standards via auditing, verifying and validation.
  • Maintain a constant pulse on the industry's regulatory environment both current and future and be proactive in taking appropriate measures and communicating compliance strategies.
  • Develop and direct Coltene's process and product compliance strategies, policies, programs and systems.
  • Direct the adequate assessment, prevention and management of issues and risks arising from company products.
  • Manage the process for submitting and maintaining product registrations both domestically and internationally, including medical device registrations, pesticide registrations, drug registrations and electrical safety registrations.
  • Strive for continuous improvements to the regulatory processes.
  • Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.
  • Prepare, track and maintain operating budgets.
  • Adhere to and promote all organizational policies and procedures.
  • Ability to manage remote teams.
  • This position supervises and manages all direct reports and is responsible for the performance and hiring of those employees. 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 required
    • 3-5 years of progressive experience in regulatory affairs required
    • Tangible management/leadership experience
    • Appropriate combination of education and experience may also be acceptable
    • In depth knowledge of 21CFR 820, ISO13485 and MDD/MDR QMS requirements
    • Working knowledge of obtaining market authorizations
    • Experience with medical device products preferred
    • ASQ, Six Sigma, RAPS or other regulatory certifications desired
    • 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
    • Project management experience
    • Strong interpersonal communication skill set
    • Organizational skills
      Working conditionsWhile 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 / Research and Development. 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 requirementsWhile 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. Direct reportsTeam of Regulatory Affairs Specialists
      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

Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Regulatory Affairs Manager, Executive , Cuyahoga Falls, Ohio

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