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.
Detailed Description The Sr. Reg Affairs Specialist develops and implements regulatory strategies and guidance for Latin America and Asia Pacific business based on International requirements as defined in FDA regulations, ISO 9001 Standards, ISO 13485:2003 Standard and other International Regulations.
Job Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES
DESIRED MINIMUM QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.
- Responsible for managing and providing Regulatory strategy for Latin America/Asia Pacific products.
- Manages the planning and filing of documentation with all international regulatory agencies.
- Ensures that the team 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.
- Leads relevant regulatory project planning and review meetings; conducts the final document review and corrections.
- Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials needed.
- Ensures the team prepares Design Dossiers, Technical Files, DAL’s (Distributor Authorization Letters) and other International Registrations proactively to protect our commercialization opportunities.
- Manages all document preparation and responses to distributors, governmental bodies, supplements, and amendments.
- Manages the preparation of the department’s budget; ensures that the department operates within capital and expense budget guidelines.
- Monitor the international regulatory environments, and provide executive management with assessments of the impact of new and changing regulations.
- Review product complaints for MDR reporting, EU Vigilance and Canadian Medical Device reporting as required.
- Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials as needed
- Write departmental SOPs as needed
- Performs other duties as required.
TOOLS AND EQUIPMENT USED General office equipment, computers, specialized software programs including Microsoft Word, Microsoft PowerPoint, Excel, Access, etc.
- Bachelor's degree
- 4-6 years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for device and/or drug, biologic products.
- Bilingual (Spanish, Mandarin, Japanese, Portuguese)
- Experience working with OUS authorities such as COFEPRIS, ANVISA, PMDA, KFDA, SFDA
PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.
Ability to travel via car and/or airplane to domestic and international locations as needed.
ADVERSE WORKING CONDITIONS There are no adverse working conditions associated with this position.
SELECTION GUIDELINES Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
DISCLAIMER The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
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.
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