Regulatory Affairs Manager
Company: Coltene Whaledent, Inc.
Location: Cuyahoga Falls
Posted on: January 13, 2022
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
- 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
- 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
- Tangible management/leadership experience
- Appropriate combination of education and experience may also be
- In depth knowledge of 21CFR 820, ISO13485 and MDD/MDR QMS
- Working knowledge of obtaining market authorizations
- Experience with medical device products preferred
- ASQ, Six Sigma, RAPS or other regulatory certifications
- Proficient in Microsoft Office Suite (Word, Excel, Project,
Visio, Power Point, Outlook)
- Problem solving/analysis including statistical process
- Technical capacity including decision making, communication and
- 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
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
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
Keywords: Coltene Whaledent, Inc., Cuyahoga Falls , Regulatory Affairs Manager, Executive , Cuyahoga Falls, Ohio
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