Integra LifeSciences Sr. Regulatory Specialist in Billerica, 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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Sr. Regulatory Affairs Specialist will develop and implement global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations. This individual prepares on time medical device submissions for US and EU. This individual facilitates timely regulatory clearances/approvals. This individual represents regulatory affairs on project/product development teams. This individual reviews and approves product/facility change orders and labeling/promotional material. This individual assists with international registration requests to support international growth. 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.
Under direct supervision of Regulatory Affairs Director or Regulatory Affairs Manager
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.
Supports Regulatory Vice President, Regulatory Director and Regulatory Managers in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
Participates in health hazard assessments and regulatory field actions
Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups
Develops and coordinates global regulatory strategies and regulatory plans
Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications
Coordinates and prepares responses to FDA/NB or other such regulatory agency letters.
Prepares 510(k) Decision Trees as required to support engineering change orders
Reviews and approves product labeling changes
Reviews and approves promotional literature and marketing materials
Reviews and approves rework of non-conforming product
Reviews and approves supplier quality files/documents
Reviews and approves Medical Device Reports (MDR)
Support CAPA closure
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
This individual must have at minimum a Bachelor’s degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in preparing global regulatory strategies for medical devices. This individual must have proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications. This individual must possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies. The individual must have strong writing, data analysis, and communication skills. The individual must have the ability to handle multiple demanding projects.
A Bachelor’s degree (or international equivalent degree) in biology, chemistry, engineering or related technical field is desired. Equivalent work experience will be considered.
Vacancy ID 2017-21055
Position Type Regular Full-Time
Category Regulatory Affairs