Description
Our client, Medical device manufacturing is seeking a Regulatory affairs associate to join their team. Reg Affairs, IVD or Medical Device, Project Management, previous Abbott would be ideal.
We are transferring the legal manufacturer for a number of third-party manufactured products from ***** in Chicago to **** in Sligo, Ireland. These products will also be transitioned from the EU IVDD to the EU IVDR. The worker will be supporting this transfer and IVDR transition from a regulatory perspective, e.g., reviewing and approving Tech File and PMS documents, providing design plan Reg assessments, and responding to questions from internal and external stakeholders. Minimum Experience: 5 years of experience, preferably in IVD regulatory affairs.
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review and approval of engineering study protocols and reports and validation study protocols and reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; a proven successful track record of authoring, submitting, and receiving approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
Roles and Responsibilities
- Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand and investigate regulatory history and background of class, diseasetherapeutic context, and diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles. Participate in risk-benefit analysis for regulatory compliance.
- Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
- Assist in the preparation and review of regulatory submissions to authorities.
- Maintain annual licenses, registrations, listings, and patent information.
- Assist in compliance with product post-marketing approval requirements. Assist in the review of advertising and promotional items.
- Assess external communications relative to regulations. Review the regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Contribute to the development and functioning of the crisis and issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
- Individuals may provide limited work direction and guidance to peers and/or skilled non-exempt employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks with approval. Initiates or maintains a work schedule. Establishes priorities for work assignments. May lead a departmental project team.
- Establishes and cultivates an extensive network of support to facilitate the completion of assignments.
- Participates in determining goals and objectives for projects.
- Influences middle management on technical or business solutions.
- May interact with vendors.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
