Essential Duties:Manage 510(k) submissions.Responsible for ensuring that technical documentation and the EU declaration of conformity are drawn up and kept up to date.Author, coordinate, prepare, or review regulatory submission in multiple countries including but not limited to the US, UK, EU, Canada, Saudi Arabia, Malaysia, Singapore, Mexico, United Arab Emirates, China, Pakistan, Indonesia, Australia and many others.Responsible for ensuring post-market surveillance obligations are met.Responsible for medical device reporting obligation in all applicable countries such as reportable events, serious incidents and any other reporting required or requested from various regulatory agencies.Interpret regulatory rules and rule changes and ensure they are communicated throughout the organization.Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.Advise project teams on premarket regulatory requirements, export and labeling requirements.Monitor compliance activities of competitors.Responsible for recalls, FSCA and FSN in all applicable countries.Responsible for device registration, listing, licensing, and shipping restrictions for all regulatory jurisdictions where Microbiologics' products are marketedReview and approve marketing materials.Review and approve labeling including product inserts.Provide training and guidance as needed throughout the organization.Establish and manage international regulatory strategies and priorities.Assist distributors with documentation requests related to various regulations they may need to navigate.Review or write GLP protocols when applicable.Participate in internal audits across multiple facilities.Write and update SOPs related to the position.Manage product shipping restrictions in NetSuite.Other duties as assigned.Education/ExperienceBachelors degree preferably in a scientific, engineering or regulatory field.3 years previous experience in medical device/IVD regulatory affairs required.Submission experience required.Regulatory experience with the European Union and the United States is required.Regulatory experience with other countries is preferred.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)Equal Opportunity Employer minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
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