Integra LifeSciences Specialist, International Regulatory Affairs in Mansfield, Massachusetts
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and 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’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is 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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Regulatory Affairs Specialist will develop and implement global regulatory strategies based on international regulations to register Integra’s Codman products globally. This individual prepares on time medical device submissions and facilitates timely regulatory clearances/approvals. This individual represents regulatory affairs for new products registrations, changes in intended use and product/design changes as well as manufacturing transfers for international markets. This individual works with their manager to prioritize regulatory workload based on compliance and business objectives. This individual works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.
Represent International regulatory affairs on project planning and project teams
Working with department management provides International regulatory guidance to cross-functional groups
Develops and coordinates International regulatory strategies and regulatory plans
Working with department management, communicates with international regulatory authorities
Coordinates/prepare and maintains regulatory submissions according to country registration requirements to facilitate product approvals in International regions.
Manages regulatory registration projects and maintains list of product approvals for International regions
Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
Participates in regulatory audits/inspections as required
Writes SOPs and train key personnel as needed
Perform other duties as assigned
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
2-4 years regulatory experience in a medical device company.
Demonstrates strong writing and communication skills
Strong attention to detail, ability to multi-task
Knowledge of overall business environment
Ability to learn and stay abreast of regulations pertinent to medical devices
Ability to function well as a member of the team and build relationships between RA and other areas of the organization
Ability to speak another language a plus
Vacancy ID 2018-26635
Position Type Regular Full-Time
Category Regulatory Affairs