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Specialist, Regulatory Affairs

Company: Integra LifeSciences
Location: Princeton
Posted on: June 24, 2022

Job Description:

Specialist, Regulatory Affairs USNJPrinceton, Vacancy ID2022-42210 Career Home Job Search Results Specialist, Regulatory Affairs 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. Integras common stock is listed on The NASDAQ Stock Market under the symbol IART. RESPONSIBILITIES Responsibilities The Regulatory Affairs Specialist is an intermediate level role responsible for implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Responsibilities include analysis and review of data, resolution of regulatory issues of moderate scope, maintenance/update of existing technical files and ensuring that new products are compliant to new requirements. SUPERVISION RECEIVED Under direct supervision of People Leader per current Regulatory Affairs organizational chart. SUPERVISION EXERCISED None ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business. Provide regulatory input to cross-functional teams. Works mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions. Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions. Author draft submissions under supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Under supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. Begin to interact with Regulatory Body personnel under direct supervision. Actively assist with upcoming audits and certification reviews with all Company designated Notified Bodies. Support communication with the Companys Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews. Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements. Review promotional and advertising material for adherence to approved product claims and regulatory compliance. Work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations. Coordinate rollouts of product changes with corporate and international regulatory teams. Coordinate Unique Device Identification system requirements and other labeling compliance of new products introduced into the market. Work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971 under supervision. Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. Works under moderate supervision. Review labeling that requires regulatory review and approval to ensure compliance with government regulations. Problem solving: Apply company policies and procedures to resolve a variety of issues of moderate complexity; Provide solutions to a variety of problems of moderate scope and complexity. Participate in continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned. Contribute to the authoring of SOPs. Perform other duties as assigned. QUALIFICATIONS What are we looking for? Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. EDUCATION & EXPERIENCE: Bachelors degree in Science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 2 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 1 year in Regulatory Affairs and the other year can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met: RA Certification (RAC) can count towards 1 year of specific RA experience Masters degree can count towards 2 years of relevant (non-RA) experience Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience. COMPETENCIES & SKILLS: Experience in working effectively with cross-functional teams (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Experience with medical device, biologic 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, with supervision. 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. Must have strong writing, project management and communication skills. Demonstrated skills in contributing to multiple projects simultaneously. Established skill in objective thinking. Brings proposals for solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and intermediate submission components, based on templates. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Ability to communicate effectively in both informal and formal settings. Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job. TOOLS AND EQUIPMENT USED Ability to utilize a computer, personal electronic devices, as well as other general office equipment. Strong computer skills are required. PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs. TRAVEL It is estimated 5 15% travel may be required for this position. Ability to travel via car and/or airplane to domestic and international locations as needed. ADVERSE WORKING CONDITIONS There are no adverse working conditions associated with this position. 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 ( -EOE including Disability/Protected Veterans ( 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 ( . If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at 855-936-2666. Please see our Privacy Policy ( . 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 ( . 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 ( with any questions or search this site for more information. Copyright 2020 Integra LifeSciences Corporation. All Rights Reserved.

Keywords: Integra LifeSciences, Trenton , Specialist, Regulatory Affairs, Other , Princeton, New Jersey

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