Integra LifeSciences Regulatory Affairs, Specialist - Orthopedics & Tissue Technologies in Plainsboro, New Jersey

Overview

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."

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Using a broad base of knowledge and understanding of regulatory requirements, this person help lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for our International business.

  • Evaluates regulatory issues, develops regulatory strategies and revises technical documentation for upcoming regulatory submissions for orthopedic products.

  • Actively assists with our upcoming audits and certification reviews with Notified Body (BSI).

  • Reviews promotional and advertising material for adherence to approved product claims.

  • Works in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with European and International regulations.

  • Coordinates roll-outs of product changes with corporate and international regulatory teams.

  • Ensures timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.

Qualifications

DESIRED MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Bachelor’s degree in science or other technically related field, or equivalent work experience.

  • Minimum of 3 years regulatory experience with increasing responsibility in a medical device or pharmaceutical company.

  • Experience in working effectively with cross-functional teams; especially with manufacturing sites.

  • Experience with orthopedic or implantable products is preferred, but not required.

  • Awareness of business strategies and tactics, including an understanding of regulatory impact.

  • Must have proven ability to prepare and submit documents to regulatory agencies.

  • Ability to explain regulatory requirements and pitfalls to project teams and colleagues.

  • Can communicate existing facts in an organized and clear manner to cross-functional teams.

  • Must be detail oriented, well-organized and able to work both independently and in teams.

  • Must possess and demonstrate an understanding of FDA requirements and quality system requirements.

  • Demonstrated sense of humor, and the capacity to enjoy working in a great team.

  • Must have strong writing, project management and communication skills.

  • Demonstrated skills in contributing to multiple projects simultaneously.

  • Awareness of business strategies and tactics, including regulatory impact.

  • Can communicate facts in an organized and clear manner to cross-functional teams.

  • Established skill in objective thinking.

  • Provides regulatory input to cross-functional teams.

  • Brings proposals for solutions to identified issues.

  • Develops plans to meet pre-defined Regulatory goals.

  • Responsible for tasks and simple submission components, based on templates

  • Ability to explain regulatory requirements and pitfalls to project teams and colleagues.

  • Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.

  • Willingness to take ownership and accept responsibility for actions and decisions.

  • Must be detail oriented, well organized and able to work both independently and in teams.

  • Ability to communicate effectively in both informal and formal settings

  • Regulatory Affairs Certification (RAC) is a plus, and can be obtained on the job.

Vacancy ID 2018-27057

Location US-NJ-Plainsboro

Position Type Regular Full-Time

Category Regulatory Affairs

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 stat