Are you based in NJ USA?
Are you looking for an exciting new opportunity?
Do you have experience managing a team and working within regulatory affairs for medical devices?
Does this sound like a great fit for you? Then apply below!
* Provides regulatory leadership to meet expected industry standards, applying in-depth knowledge of client specific and regulatory requirements and guidelines, procedures and best practices, including compliance.
* Preparing regulatory submissions of class I, IIa, IIb and III devices for global markets
* Developing preliminary regulatory strategies for key markets in support of new product development activities.
* Monitoring activities of regulatory agencies and industry organization’s to identify any changes in regulations and communicating this information to the company.
* Providing a regulatory perspective on validation and stability reports and post marketing surveillance
* Maintaining registration documentation necessary to support international market registration objectives for medical devices i.e. technical files, Design Dossiers, IFUs, product labeling, Declarations of Conformity, Clinical Evaluations
* For assigned project(s), as requested and monitored by the client’s project lead(s)/team(s), act as an accountable agent on behalf of the client to Global Regulatory Bodies – and lead and support regulatory team (cross sub functions of regulatory including documentation, CMC, submissions, labeling) or equivalent members for related activities.
* Provide experienced stakeholder management interfacing directly with internal stakeholders of various levels.
* Provide additional regulatory and project-related support activities/Services as requested by the client project leads/teams.
* Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Affairs-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant best practices and tools as appropriate
* Consistently complies with all governing laws, regulations, client SOPs and other guidelines
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