Integra LifeSciences Senior Regulatory Specialist in Mansfield, Massachusetts
Senior Regulatory Specialist
US–MA–Mansfield, Vacancy ID2021-38645
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Changing lives. Building careers.
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.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
Under minimal supervision: Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches, including submissions to transition devices from MDD to MDR compliance. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials and helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
Ensures compliance with regulatory agency regulations and interpretations
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
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
Review and approve promotional material
Review change orders to ensure regulatory compliance
Support the transition, including leading submissions where required, for the transition of devices from MDD to MDR
What are we looking for?
Degree in engineering or a science discipline required for this position. At least 5+ years’ experience in an RA role, or equivalent medical device industry role (i.e.quality, engineering,etc.)
Excellent written, verbal communication and presentation skills.
Experience in the preparation and submission of US and EU regulatory filings.
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.
In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.
We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.
We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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