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| During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. |
| TRAINING: Employee Error |
| Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275. |
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Inspections, Compliance, Enforcement, and Criminal Investigations
Midmark Corporation 12/28/11
Several failures to document during production and final testing
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Health equipment maker Midmark gets FDA warning letter on sterilizers
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REGULATORY SPECIALIST ** Medical Device ** FDA
Midmark Corporation - Versailles, OH
Posted 11 days ago View full job listing
This is a preview of the REGULATORY SPECIALIST ** Medical Device ** FDA job at Midmark Corporation. To view the full job listing, join LinkedIn - its free!
About this job
Job description
Midmark Corporation, a healthcare equipment company located in Versailles, OH, is seeking a Regulatory Affairs Specialist.- Are you a medical device expert who enjoys leading and providing guidance?
- Do you have a passion for quality?
- And, would you thrive in a privately held team-oriented company?
OPPORTUNITY:
As our Regulatory Affairs Specialist, you will be responsible for implementing the global introduction and continued approval/licensure of new and revised products. You will provide subject matter expertise and be responsible for advising and guiding the local organization on regulatory topics. You are also the primary liaison to Marketing and Sales groups with regards to regulatory requirements for marketing communications and other customer-facing communications. Reporting to the Director of Regulatory Affairs, you will play a key role in our Regulatory department as we continue to grow!
KEY ACCOUNTABILITIES:- Prepare FDA submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.
- Lead and provide guidance to work teams comprised of senior engineering and marketing personnel with regards to regulatory planning and execution.
- Review and analyze product complaints for appropriate domestic and international filings as part of product post-market surveillance.
- Advise technical, marketing, and sales teammates on regulatory requirements (e.g., Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion).
- Provide guidance and review of product labeling, promotional material, change control and other related product documentation.
- Maintain database(s) for the worldwide regulatory status of products.
- Monitor industry and regulatory trends and develop strategy and provide guidance related to such trends.
- Support the development and implementation of the regulatory department’s policies and procedures and strategic objectives.
Desired Skills and Experience
SUCCESS FACTORS:- Bachelor Degree in engineering or life sciences.
- 5 years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
- Experience with product registration requirements, US, Canada, EU and other major international markets i.e. china, Australia, Brazil, Saudi Arabia, etc.
- Experience in the preparation of 510(K) submissions.
- Experience in development and post market support of Class 1 and 11 Medical Devices.
- In collaboration with Regulatory management, lead submission activities for devices in gaining required clearances through the processes of IDE’s 501 (k)s, PMA’s, CE marking and combination products.
- Knowledge of international quality and product standards for medical equipment (e.g. ISO 14971, ISO 13485, EN60601, IEC 62304, etc.)
- Strong project management and organizational skills.
- Excellent verbal and written communication skills.
- Strong analytical and problem solving skills.
About this company
COMPANY:
Midmark Corporation is the most trusted name in medical, dental and animal health equipment solutions. Midmark provides innovative products and services for the healthcare professional, integrating value-added technology into everything it does. With over 1400 teammates worldwide, Midmark is dedicated to making a positive difference in the practice of healthcare. Midmark has five locations in the United States and subsidiaries in France, India and Italy.
COMPENSATION AND BENEFITS:
Midmark Corporation will reward your talents with a total compensation package commensurate with experience. You will also receive a generous benefits package including medical, dental, vision, life insurance, long-term disability, a 401K plan, and tuition reimbursement! Plus, a relocation assistance package is available!
APPLY NOW:
If you are a medical device compliance expert who enjoys providing guidance, we encourage you to apply online now.
To learn more about Midmark Corporation, please visit www.midmark.com
Midmark Corporation requests that all candidate communication and recruiter inquiries be directed to Safari Solutions.
Drew Smith, HR Consultant
Safari Solutions
[email protected]
Keywords: life sciences, medical device, regulatory, health products, medical devices, regulations, management, ISO 9001, ISO 13485, FDA 21CFR820. 100, regulatory affairs, regulatory compliance, dental devices, healthcare equipment, animal health, 510K submissions, design control.
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