Regulatory Affairs & Compliance Specialist

IsoTis OrthoBiologics a division of Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. In 2006, Integra grew revenues by more than 50% and surpassed $1 billion in market capitalization. We anticipate our significant growth to continue. In 2005 and 2006 Integra LifeSciences was named to the Forbes 200 Best Small Companies list, and has recently been named 2007 Medical Device Manufacturer of the Year by Medical Device & Diagnostic Industry Magazine.  Our rapidly growing company of over 2500 employees is currently seeking a highly accomplished professional committed to taking us to even higher levels of growth and innovation. 

SUMMARY DESCRIPTION

· Responsible for supporting regulatory and quality assurance functions including planning and filing of documentation with domestic and international agencies, compliance with regulations, planning related to regulatory compliance and approvals.  Will ensure that customer requirements are met.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES· Responsible for assisting in regulatory functions including planning and filing of documentation with domestic and international agencies, compliance with regulatory requirements and ensuring customer requirements are met.

· Interfaces with Plant staff for regulatory and compliance issues.

· Manages all Company, FDA, State, Tissue Bank and other  licenses to ensure documentation packages are prepared and submitted to ensure timely renewal.

· Supports and assists in the preparation of 510k, PMA’s or IDE’s for FDA on new or substantially changed products.

· Prepares and submits dossiers to support  International Regulatory Agencies or Notified Body in the European Union for review and approval.  Prepares technical files as required.

· Reviews and approves all Engineering changes for regulatory impact for FDA, International Regulatory Agencies, Notified Body in the EU, Canada, Japan and ROW.

· Supports corporate Product Development process as related to regulatory inputs and decisions Provides regulatory and CE documentation for international registrations, as required.

· Maintains current status of FDA submissions, international registrations, and CE Mark dossiers and technical files.

· Manages the Internal Audit program in compliance with QSR, ISO 13485:2003, CMDR and AATB requirements, and performs internal audits as required.

· Helps provide training for all newly hired personnel on subjects related to regulatory issues, related Quality Systems, MDD, and compliance requirements.

· Maintains compliance with CE Marking of product sold in the EU.

· Reviews Product Experience Reports and Complaints for Regulatory input and MDR/Vigilance reporting determination.

· Supports and participates as required in all respective agency audits and responses to support audit findings or other respective actions related to such audits.

 DESIRED MINIMUM QUALIFICATIONS

 · Education

BS Degree in Life Sciences, engineering or related field. 

 

· Experience

Minimum five years related experience in the medical device industry.  Thorough knowledge of QSR, MDD, ISO 13485:2003, Canadian Medical

 

 

  We are committed to creating an enviroment where all employees are valued and respected. We offer competitive compensation/benefits package including 401(k) savings plan with match, medical, vision, dental, life insurance. Please forward all resumes and salary requirements to: hr@isotis.com . Please state Regulatory Affairs & Compliance Specialist in the subject line. Website: http://www.integra-ls.com/. No agencies please.