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Regulatory Affairs Manager - 75% Remote

Omron

Hoffman Estates, IL

Not provided

$1 - $9,999,999

1 month ago

Job Description

Regulatory  Affairs Manager -- Helping You Live Your Healthiest Life!

Omron is a growing Company headquartered in Hoffman Estates, IL that offers its employees opportunities for career growth, a true work-life balance and a culture that recognizes the importance of giving back to society.

The Company:

Omron is a forward thinking and innovative company that is known for the great care we take with consumers, customers, and employees alike. We are dedicated to creating medical solutions to help you better manage your health based on technology that fits seamlessly into your everyday life. We believe in improving lives and contributing to a better society.

 

POSITION SUMMARY:    

This position will assure that all OHI products are of high quality by developing, maintaining and managing the Quality System for compliance with FDA, ISO, Canadian Medical Device and other International Ministry of Health requirements applied to currently approved products and products under development.

 

RESPONSIBILITIES:    Manage Labeling and Ad/Promo reviews including communication and education of regulatory requirements for FDA, ISO, CMDR, IEC, and Prop 65. Manage regulatory registrations with FDA, Canada, individual state registrations, and GUDID. Conduct 510k decision checklists, LTF, and 510k submission reviews. Work closely with R&D in Japan and 3 rd party consultants to compile 510k submissions, FDA pre-submission, and participate in FDA pre-submission meetings. Keep abreast of new and changing regulations and technical literature in general field as well as those pertaining specifically to assigned projects. Demonstrate capability to communicate and work effectively with OHQ R&D, offshore manufacturing and with marketing for new product launch. Maintain high visibility and interaction with team members to foster collaboration and teamwork. Interact with other departments, manufacturers, and suppliers. Identify solutions and execute solutions to existing processes, and develop new quality system processes to ensure compliance with applicable guidelines for medical devices. Provide coaching and advice to managers and employees on practical application of Quality System requirements. Participate and/or lead continuous improvement initiatives for development and execution.  Identify the improvement, develop the solution, lead the execution, and engage other functional areas as needed. Report progress to executive management team. Function as backup for Product Administrator. Conduct internal and supplier audits.  Assist with 3 rd party regulatory audits. Complete other tasks as assigned.

 

EDUCATION, EXPERIENCE AND CERTIFICATIONS: Education:  Degree in the Sciences Experience:  Minimum 7 years’ experience in medical device or pharmaceutical.  Experience in interactions with FDA, other regulatory authorities, and/or ISO/CMDCAS notified bodies required.

 

KNOWLEDGE, SKILLS AND ABILITIES - The responsibilities listed below are representative, but not all inclusive of the knowledge, skill, and/or ability necessary to satisfactorily and successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. Technical Abilities:  Well-developed PC skills, knowledge of Microsoft applications (Office, Excel, etc.) or equivalent required. Behavioral Profile: Advanced planning, organizational and time management skills. Able to handle multiple projects simultaneously. Advanced attention to detail and problem solving skills. Self-motivated and able to work independently. Strong listening, written and verbal communication skills. Ability to communicate professionally and responsibly with a variety of individuals at all levels of the organization. Strong presentation skills a must. Ability to understand business terms and processes. Ability to multi-task, work cross-functionally and independently with strong organizational skills. Excellent people skills. Ability to analyze processes and information, identify problems and trends, and develop effective solutions and strategies

 

QUALIFICATION REQUIREMENTS - The requirements listed below are representative of the physical and environmental factors the jobholder will encounter. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.  Physical Requirements: While performing the responsibilities of the job, the employee is often required to talk, hear at normal speaking levels, sit and use their hands and fingers to type, handle or feel, including repetitive motions with the wrists, hands and fingers. The employee is occasionally required to stand, walk, and reach with arms and hands, this is a sedentary position involving sitting most of the time. Vision abilities required by this job include close vision for extensive computer use, reading and visual inspections. Environmental Factors: While performing the duties of this job, the employee is primarily in a general office environment and occasionally in other. The noise level in the work environment is usually quiet to moderate. The position is not substantially exposed to adverse environmental conditions. Travel Requirements: Potential travel to Japan

 

CONCLUSION:  This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed by jobholders within this job. However, this job description is not intended to be an exhaustive list of qualifications, skills, efforts, duties, responsibilities or working conditions associated with the position.

 

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