Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Integra LifeSciences Senior Regulatory Specialist in Mansfield, Massachusetts

Senior Regulatory Specialist

US–MA–Mansfield, Vacancy ID2021-38645

Career Home › Job Search Results ›Senior Regulatory Specialist

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.”

RESPONSIBILITIES

Responsibilities

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

QUALIFICATIONS

What are we looking for?

Qualifications

Qualifications:

  • 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.

OUR PRODUCTS

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.

OUR CULTURE

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.

OUR VALUES

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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) |EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Please see our Privacy Policy (https://www.integralife.com/privacy) . Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to our Terms of Use (https://www.integralife.com/terms) . You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Integra Life Sciences. Contact Us (https://www.integralife.com/contact) with any questions or search this site for more information.

© Copyright 2020 Integra LifeSciences Corporation. All Rights Reserved.

DirectEmployers