Omron Automation Hiring for Regulatory Affairs Manager – % Remote at Hoffman Estates, IL  Full Time

Work at OMRON!

OMRON is the world’s leading manufacturer and distributor of personal heart health and wellness products. Since OMRON invented its first blood pressure monitors more than 40 years ago, the company has been passionate about empowering people to take charge of their health at home through precise technology. OMRON provides the World’s #1 Blood Pressure Monitor (Global Home Appliance Market Comprehensive Survey 2020 by Fuji Keizai Co., Ltd. (2019)). The company’s mission is Going for Zero, the elimination of heart attacks and strokes. Omron Healthcare – US, headquartered in Hoffman Estates, IL, is the healthcare subsidiary of Omron Corporation, a $8 billion global technology company celebrating more than 80 years of success.

Omron also has recently launched VitalSight by OMRON. VitalSight by OMRON is a remote patient monitoring (RPM) program committed to supporting healthcare organizations in realizing remote care’s potential for blood pressure management. VitalSight was developed in response to OMRON’s nearly 50 years’ experience in supplying clinically accurate home patient monitoring devices and personal heart-health technology. As a leader in at-home monitoring devices, it only makes sense that OMRON designed VitalSight to make participation in a clinically relevant remote patient monitoring program easier for both patients and providers-all in pursuit of Going for Zero mission.

Regulatory Affairs Manager

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.

Our Commitment to Employees:

• Training and Career Development Program to give employees a learning path with the necessary tools and resources they need to help build their career at Omron.
• Great financial opportunities with competitive compensation, immediate 401k match with 100% vesting, profit sharing, and Blue Cross Blue Shield for medical, dental, vision and prescription drug benefits.
• Community Programs that includes activities with local non-profit organizations and a Matching Gift Program.
• Work-Life Balance with Flexible Work Arrangements, Flexible Work Hours, and Sick/Vacation/Holiday Pay.
• Wellness Programs such as Walking Contests, Nutritional Learning Sessions, On Site Flu shots or Health Screenings, etc.
• Education Assistance Program.

Responsibilities:

• Manage Labeling and Ad/Promo reviews including communication and education of regulatory requirements for FDA, ISO, CMDR, IEC, and Prop 65.
• Conduct 510k decision checklists, LTF, and 510k submission reviews.
• Prepare, or direct consultants in preparation of, required regulatory filings, including 510k for FDA clearance. Work with Omron Healthcare Headquarters to ensure required registration of products for all countries in which Omron Healthcare, Inc. operates.
• Communicate adverse events and/or potential adverse events to the FDA, Health Canada and OHQ (MDR’s and 30 day notices)
• Manage regulatory registrations with FDA, Canada, individual state registrations, and GUDID.
• Work closely with R&D in Japan and third party consultants to compile 510k submissions, FDA pre-submission, and participate in FDA pre-submission meetings.
• Manage Human Factors and Usability testing including the creation of the protocol, recruiting, moderating, and writing summary report.
• Review and approve P1 documentation for QA/RA and generate P2 memos.
• Maintain current state licensing.
• Ensure compliance with all applicable laws and regulations. Maintain up to date knowledge of regulatory standards. Conduct quarterly audits to identify areas of non-conformance.
• Keep abreast of new and changing regulations and technical literature in the 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.
• Function as backup for Product Administrator.
• Conduct internal and supplier audits. Assist with third party regulatory audits.
• 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.
• Complete other tasks as assigned.

Job Requirements:

• Degree in the Sciences or equivalent 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.
• Well-developed PC skills, knowledge of Microsoft applications (Office, Excel, etc.) or equivalent required.
• 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.

Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Omron we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

Omron is an Equal Opportunity Employer. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, we comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.