Reulatory Affairs

Greater Cincinnati, OH

Challenging Regulatory Affairs Opportunity

Recognized worldwide leading pharmaceutical company

Executive Search, Ltd. has partnered with our client to identify and locate top quality candidates for their organization. For close to a century our client has been incorporating customer focus, flexibility, teamwork and employee pride in growing their success. They embrace and encourage innovative thinking, challenges and opportunity for continued growth. Over 11% of annual revenue is dedicated for R&D. Because of this commitment they are continuing to grow both from the R&D efforts and, also, through acquisition of key players.

The Medical Device Specialist will assume the responsibility for regulatory compliance of a portfolio of medical devices used with contrast media. The Regulatory Affairs personnel in the Cincinnati office are responsible for , and also assembling dossiers for global submissions worldwide of my client's device line. The RA-MD Specialist plays a key role in new product development teams and device change implementation.

• Prepare domestic and international submissions (including CE-mark dossiers) for new products and product changes to facilitate timely approval of market access. Communicates directly with US and international affiliates and regulatory personnel.
• Cmpose dossier content for new device registrations and variations
• Represent Regulatory on product development teams, developing/executing regulatory plans and providing regulatory impact information for project options.
• Provide support to new and currently marketed products including labeling advice and post market follow up activity requirements.
• Ensure files maintain compliance with regulatory requirements.
• Will work closely with several internal departments, as well as, external .
• Ensure company compliance with all r4equired Federal, State, Local and International agencies as they relate to regulations, policies, and procedures.
• Development of and Training of operating procedures and work instructions.

Required Skills & Background

• 2-4 years work experience in Medical Device Regulatory Affairs, preferably with successful FDA and EU-notified bodies submission experiences.
• Good understanding of US, EU, Canada regulations on medical devices
• Experience with medical device product registration and licensing is required.
• Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
• Strong written and verbal communication skills. Multi tasking and detail oriented capabilities.
• Required Bachelor's degree. Prefer in biological field, medical science, materials science or engineering.
  

APPLY NOW

To be immediately and seriously considered for this outstanding career opportunity, send your resume in assured confidence to Terry Cimino: 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.

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

a tradition of excellence since 1974