Job Title Regulatory Affairs and Design Assurance Associate
Location Cincinnati, OH
Job Type Full-Time Regular
Job Description

REGULATORY AFFAIRS AND DESIGN ASSURANCE

 

Greater Cincinnati, OH

 

Dynamic Lead Regulatory Affairs Opportunity 

Global leader manufacturer of innovative diagnostic test kits for Biotech



My client is a multi-million dollar market leader. My client's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. They are a leader in their market and is a fuilly integrated life sciemnce company that manufactures, markets and distributes a broad range of innnovative diagnostic test kits, purified reagents and biopharmaceutial enabling tehcnologies that deliver answers.  The Company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices and diagnostics manufacturers in more than 40 countries around the world. These products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions. My client's product-development strategy is driven by three core concepts -- speed, simplicity, and accuracy -- all of which contribute to patient well-being and reduced healthcare costs. They have acquired, licensed or entered into supply arrangements relating to approximately 100 new products. They have been named multiple times  by Fortune Small Business - Fastest Growing Small Companies, Forbes Best 200 Small Companies, Business Week 100 Hot Growth Companies and multiple other accomplishments.  The company has over 40 years in industry.

They work hard, respect their talented and ambitious colleaguies and achieve strategic goals as a team. They believe that work should be fun and enjoyable as well as meaningful and productive.  They offer a vareity of events throughout the year that offers a chance to relax and enjoy the camaraderie of fellow associates. 

The Regulatory Affairs and Design Assurance professional, Level I (RADA I) will be responsible for supporting Product Realization Process and ensuring products are designed and manufactured in a manner consistent with applicable Regulatory Requirements. The RADA Associate will be responsible for ensuring product compliance throughout all stages of the product lifecycle: Research, Development, Transfer, Validation/Verification, Labeling, Regulatory Application and Lifecycle Maintenance. The RADA Associate will work with cross-functional teams to provide Regulatory guidance in support of business objectives.  

KEY DUTIES:

  • Provides Quality and Regulatory support to Design Control activities, including research and development, design transfer, clinical trials, validation and verification for new product introductions and existing product modifications. The RADA professional will serve as the Quality Assurance/Regulatory Affairs Project Team Representative for design projects.
  • Prepares product regulatory submissions in support of world-wide commercialization and business objectives.
  • Evaluates technical protocols and data in support of Clinical Trials, Validation, Verification and product manufacturing.
  • Directs activities associated with adverse events, medical device reportable events and product recall activities.
  • Evaluates regulatory impact of changes associated with product design change and routine change control.
  • Drafts and reviews product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
  •  Provides regulatory input to product lifecycle planning.

Education/Experience:

  • BS in Biological Science, Microbiology, Chemistry or equivalent.
  • Knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices strongly preferred).
  • A minimum of three years experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent preferred.
  • A minimum of three years of Regulatory Affairs experience is preferred, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, et cetera.
  • Knowledge of design, development and clearance of Medical Device preferred.
  • Professional certifications such as CQA, CQE or CQM/OE preferred.

APPLY NOW

To be immediately and seriously considered for this outstanding career opportunity, send your resume in assured confidence to tcimino@executivesearch.net

 

 

Compensation & Benefits:

You'll be a key member of the team and will be rewarded with an excellent salary and bonus program that is based on your experience, knowledge, ability and potential... in addition to exceptional benefits and paid relocation.

 

 

About Us:

 

Providing the highest level of professionalism and industry experience for over 30 years, Executive Search Ltd. is a specialty search firm that provides technical professionals with career advice & exceptional employment services in the areas of Engineering, Engineering Management, Quality/Regulatory, Supply Chain, Packaging Engineering Manufacturing Management and Support (i.e. Human Resources, Accounting, Distribution, Warehouse, etc), Supply Chain, Sales/Sales Management, as well as Operations and Operations Management.

 

We work closely with you along each step of the employment process to assure the greatest opportunity of reaching position & career goals... and personal needs... and to assure you of the best chances for getting the interview and the best employment offer possible.

 

To learn more about Executive Search Ltd., please browse our web site at www.executivesearch.net .

  

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