Integra LifeSciences Senior Regulatory Specialist 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.
Ensures compliance with regulatory agency regulations and interpretations.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Provides solutions to a variety of problems of moderate scope and complexity.
Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
Provides regulatory guidance to product development teams and responds to product information requests
Provide Regulatory Affairs support during internal and external audits
Assists in the development of best practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional project teams
Bachelor degree with 5-7 years of experience or PhD, PharmD, MS with equivalent experience
Excellent written, verbal communication and presentation skills.
Experience in the preparation and submission of US and EU regulatory filings, including Class III devices.Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
Consults with others to understand the benefits and risks associated with decision alternatives before making decisions.
Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
Vacancy ID 2018-27540
Position Type Regular Full-Time
Category Regulatory Affairs