Sr. Regulatory Affairs Specialist - Hach - Loveland, CO / Ames, IA

Danaher Company Description
Hach is a world leader in the manufacture and distribution of analytical instruments, test kits and reagents for testing the quality of water, aqueous solutions and air. Our products are designed specifically for quality, accuracy, and simplicity. Strengthened by our sister companies in the environmental industry worldwide, our goal for the future is to continue to provide customers with reliable instrumentation, accurately prepared reagents, proven methods, simplified procedures and outstanding technical support. We offer an environment that is team-centered, customer-driven, quality-focused, and growth-oriented. Working at Hach will provide you the opportunity for robust career development.
OUR MISSION: Ensure water quality for people around the world.
OUR VISION: We make water analysis better ? faster, simpler, greener and more informative ? via unsurpassed customer partnerships, the most knowledgeable experts, and reliable, easy-to-use products.
The Regulatory Affairs Specialist position is responsible for performing regulatory assessments and planning in support of design control activities, regulatory strategic and tactical planning, and marketing and Business Unit activities. Responsible for establishing and maintaining documentation for 510k submissions/STED files/International submissions. Understands the requirements of US, EU, and other international standards.
Acts as a core member on development teams to provide regulatory guidance, develop and execute regulatory strategies and timelines.
Prepares documents necessary for new product market approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, and technical files for CE marking. Interacts with R&D and other cross functional departments to ensure proper coordination of information and data to support global regulatory filing and BU activity.
Supports the complaints process and field action as necessary. Responsible for adverse event and medical device reporting and associated reporting and interaction with regulatory agencies e.g. FDA.
Responsible for the monitoring of legislation. Maintain detailed understanding of regulatory requirements and able to translate requirements into lean processes and implement these in Hach?s internal processes.
Regulatory review and approvals of design documentation and marketing material.
Participate in process improvements, global alignment projects and creation of SOPs in the RA area, and learn from best practices in Danaher.
Assist with and act as a resource for regulatory inspections.
Perform additional duties as assigned.
Ability to effectively work collaboratively with all functions. Viewed as a leader, motivated and engaged team player by peers, co-workers and other QMS stakeholders. (Success Factor: Builds People, Teams, and Organizations)
Actively engaged and supportive of continuous improvement and the Quality Management System. (Success Factor: Charts the Course)
Is committed to excellence and understands how daily work impacts the customer, uses this understanding to make improvements in process, products and services (Success Factor: Acts with Integrity)
Supports continuous improvement through positively coping with change; applying knowledge and skills effectively in new environments. (Success Factor: Leads Through DBS)
Quickly learns when faced with new challenges and strives to enhance his / her knowledge and skills. (Success Factor: Drives Innovation and Growth)
BS/BA in science or engineering or equivalent
Minimum 5 years of experience, 8-10 years preferred, in a medical device manufacturing environment preferably in Quality or Regulatory Affairs
Experience with U.S. (QSR 820) and EU medical device legislation (IVD, MDD)
Experience interacting and negotiating with regulatory authorities in the US and EU
Experience with U.S. medical device software requirements
Familiar with labeling, website and social media regulatory requirements, experienced in conducting reviews
2-3 years experience in new product development teams and product life-cycle management
Must be proficient with Microsoft Word, Excel, PowerPoint, Access, performing training and presentations at all levels of the company
Ability to travel up to 25%
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally required to reach with hands and arms. The employee is constantly required to sit. The employee may occasionally squat, turn/twist, or reach. The employee is constantly using hands to: finger, handle, feel or operate objects, and computer keyboards. The employee is occasionally required to walk, stand, climb, balance, stoop, bend, kneel, crouch or crawl, and talk, hear, see and smell.
The employee must occasionally lift, carry, push or pull up to 20 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment consists of an indoor, work or home office environment with good ventilation, adequate lighting, and low noise levels.
/The duties listed in job descriptions are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change. The purpose of this description is to assist in ADA compliance and is not intended for other purposes such as collective bargaining, or compensation./
External hiring into this position is contingent upon the successful completion of a pre-employment drug screen and background check and possible credit history review.
Hach is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
Danaher Corporation Overview
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. We are a globally diverse team of 59,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. We generated $16.5 billion in revenue last year. We are ranked #133 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by more than 2,000 percent.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We?re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you?ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
For additional company details, see
Organization: Hach
Job Function: Manufacturing / Operations
Primary Location: North America-United States-CO-Loveland
Schedule: Full-time
Req ID: HAC003635 1a10a5af523b4c40b19a70d19e5ddf31

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