Sr. Regulatory Project Manager Collagen

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 billon 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.  This position is located at our corporate headquarters in Plainsboro, New Jersey near Princeton.

 



 SUMMARY DESCRIPTION

Identify, review and anticipate emerging regulatory issues likely to impact Collagen products. Develop and implement regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 9001 Standards, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations and other International Regulations. Establish effective dialogue with U.S. and International regulatory authorities. Direct the planning and preparation of regulatory submissions for the company’s products. Facilitate timely product registrations and regulatory approvals.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Obtains/generates information to be submitted to regulatory authorities and prepares required regulatory submissions.

· Acts as liaison with appropriate local, national and international regulatory authorities.

· Provides regulatory guidance to clinical affairs, quality systems, manufacturing, and development groups.

· Review changes in manufacturing facilities, manufacturing procedures, and analytical methods.

· Represent regulatory on project planning and design control meetings; participates in the final company document review and approvals.

· Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials as needed.

· Coordinates and prepares 510(k) Premarket Notifications, IDEs, PMAs, INDs, NDAs, Design Dossiers.

· Prepares responses to FDA letters, supplements, and amendments; participates in FDA inspections and presentations.

· Writes departmental SOPs as needed.

· Provides input for preparation of the department’s budget; ensures that the department operates within capital and expense budget guidelines.

· Keeps apprised of new regulations, standards, policies, and guidances issued by relevant regulatory authorities that may impact the company.

· Read related regulatory publications and trade association documents; presents information about current regulatory actions.

· Assists as necessary in supporting the handling of product complaints for MDR, Vigilance, Canadian Medical Device reporting requirements and preparation of Health Hazard Evaluations as required. 

· Assist with ongoing training in Quality System Regulation, ISO Standards, and other International Regulations.

· Performs all other related duties as directed by supervisor and management. DESIRED MINIMUM QUALIFICATIONS

 · EDUCATION

 

Minimum of Associate’s degree, Bachelor’s degree, and preferably a Master’s degree in science or other technically related field, or equivalent work experience.

 TYPE AND NUMBER OF YEARS OF EXPERIENCE

· Master’s degree with 5 years experience, or Bachelor’s degree with 5 to 10 years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for device and/or drug, biologic products.

· Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMA’s), Investigational New Drug (IND), or New Drug Applications (NDA).

· Must possess and demonstrate an excellent understanding of FDA, International ISO Standards, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations and other International Regulation regulatory requirements.

· Must have experience interfacing with FDA. 

· Must have strong writing, project management and communication skills.

 

 

We are committed to creating an environment where all employees are valued and respected.  We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, on-site employee gym and employee stock purchase plan.  Interested applicants should send a resume AND salary requirements to:integrastaffingJP@integra-ls.com.

 

 

To find out more about our company, visit our website at: http://www.integra-ls.com

 

No Agencies.  LOCAL CANDIDATES ONLY PLEASE.  EOE, M/F, D/V