Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery.
Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra is also a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989, Integra is headquartered in Plainsboro, New Jersey and has over 3,000 employees worldwide. For the last three years, Integra has been included in NJBIZ's list of "New Jersey's 50 Fastest Growing Companies." In 2010, we were also included in Forbes magazine's "America's 100 Best Small Companies".
We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.
The Regulatory Affairs Specialist supports the strategic planning and preparation of PMA Supplements, 510(k) Premarket Notifications and other Regulatory submissions related to the transfer of manufacturing operations to another Integra facility and other changes initiated under the collagen portfolio. The Regulatory Affairs Specialist in conjunction with collagen portfolio management and divisions develops and implements regulatory strategies and guidance based on U.S. and International requirements as defined in FDA Regulations, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169) and other International Regulations.
Assists with and/or prepares 510(k) Premarket Notifications, Regulatory Assessment Decision Trees, PMA Supplements, Change Notifications for Design Dossiers as required. Assists with and/or prepares to FDA letters, supplements and amendments Works with International Integra Regulatory representatives for strategic planning for international approvals associated with production transfers. Identify and communicate potential risks associated with strategy scenarios. Review and approve manufacturing production processes, test methods and validations as required. Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company. Performs all other related duties as directed by supervisor and management.
Job Requirements Bachelors degree with 2 to 5 years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for device and/or drug, biologic products. Masters degree with 2 years experience preferred. 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, (PMAs), 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 strong writing, project management and communication skills. How To Apply 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, and employee stock purchase plan.
To find out more about our company, visit our website at: http://www.integralife.com/Careers/
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V
Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.
Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.
When it comes to regenerative medicine, Integra LifeSciences is integral to the healing process. Using its proprietary collagen matrix...