Integra LifeSciences Senior Regulatory Affairs Manager in Billerica, Massachusetts
Senior Regulatory Affairs Manager
US–MA–Billerica, Vacancy ID2021-39987
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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.”
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of multiple variables.
Develops regulatory strategies and reviews all design transfer activities related to New Product Introductions for worldwide Regulatory Agency approval to support introduction of new and modified products to market.
Negotiates directly with regulatory authorities regarding company’s filings.
Provides advice on regulatory requirements to the organization.
Oversees and manages all regulatory aspects of the dural repair products franchise (includes 2 PMA products) ).
Manages regulatory support for Class II and Class III dural repair products.
Works in partnership with Operations and Quality to ensure regulatory compliance.
Collaborates with Clinical colleagues to develop data to support regulatory submissions and desired marketing and regulatory claims.
Manages direct reports (remote), and provides appropriate support and guidance, with an emphasis on colleague development and engagement.
Coordinates planned regulatory submissions with International Regulatory team.
Supports the growth of Integra’s dural repair franchise by providing regulatory guidance to the team, where needed.
Collaborates with Marketing to determine appropriate claims and labeling materials.
Initiates regulatory reviews and input for CAPAs, investigations, and health hazard evaluations related to dural repair products.
What are we looking for?
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor’s degree, preferably a master’s degree in science or other technically related field, or equivalent work experience.
Minimum of 10 years regulatory experience and 3 years previous management experience (or equivalent).
Regulatory experience in medical devices (CDRH), is strongly desired.
Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and/or Premarket Approval Applications, (PMAs) for changes to approved PMA products.
Experience in working with cross-functional teams on product development and manufacturing projects.
Must possess and demonstrate an excellent understanding of FDA requirements, ISO Standards, and requirements of theMedical Device TDirective (93/42EEC), EU MDR and other international requirements.
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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