Senior Regulatory Affairs Manager
Responsibilities 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. Qualifications 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 the Medical Device TDirective (93/42EEC), EU MDR and other international requirements.
Salary Range:
$150K -- $200K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
Salary Range:
$150K -- $200K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
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