Vice President Regulatory Affairs Quality Assurance

vor 3 Wochen

Frankfurt, Deutschland VIDA Connected Specialists Vollzeit

Vida are partnered with one of the fastest growing start-ups in the MedTech space. Following FDA approval of their first-to-market technology, this cardiovascular start-up is expanding their team on a global scale and is looking to add to their executive team with the addition of a VP of RA/QA. Candidates must be based in or be within commutable distance to Frankfurt.


Position Summary


This position, reporting to the Senior Vice President of Regulatory Affairs and Quality supports regulatory filings for the EMEA region and will lead the implementation and maintenance of the Quality Management System. This position is also responsible for the staffing, recruitment, and the development of the team that performs this function. This individual will ensure the distribution of the safest and highest quality products while maintaining full regulatory compliance. They will be responsible for instilling a culture of compliance with regulations and standards for the EMEA region and will act as the region’s head of regulatory and quality.


Responsibilities and Duties


Key Regulatory Affairs responsibilities will include:


  • Develops regulatory strategic plans for project teams to gain earliest regulatory approvals in EMEA. Works with project teams to resolve complex project issues. expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  • Responsible for the regulatory and quality strategy supporting commercialization and product development.
  • Assists in the design and interpretation of results for Clinical Studies required for Regulatory Approvals.
  • Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.
  • Effectively plans, organizes, and conducts (or supervises) formal meetings with regulatory agencies. Interacts with key personnel in regulatory agencies to ensure the review & approval of development plans, the timely resolution of issues, & the approval of marketing apps.
  • Tracks regulatory submissions and maintenance activities that support the EMEA region including MDD and MDR submissions.
  • Prepares elements of the Technical Files and other regulatory submissions as assigned.
  • Reviews/approves advertising & promotional materials for the EMEA for reg. compliance.
  • Maintains local copies of applicable regulatory documents including, Technical Files, Declaration of Conformity, Essential Requirements, and General Safety and Performance Requirements (GSPR)
  • Serves as the local regulatory representative for interactions with regulatory bodies in the EMEA region including competent authorities.
  • Assist with the timely filing of any required vigilance reports to competent authorities and assist with addressing any follow up questions.
  • Coordinates any required recalls, field corrective actions, and notices for the EMEA region.
  • Monitors changes in regulatory regulations, requirements, and expectations, including guidance documents, regulatory trends and significant events.
  • Manages, coaches, trains, and grows staff to be effective regulatory partners.


Key Quality Assurance responsibilities will include:


  • Strategically develops and directs site quality systems and procedures; ensures appropriate Quality Systems are in place to support and drive compliance.
  • Monitors the implementation of the quality management system in the EMEA staff and region.
  • Suggests updates to procedures or create EMEA specific versions of procedures as required.
  • Acts as the local head of quality by hosting any outside or internal audits.
  • Trains EMEA staff as required on quality management system procedures, requirements, and expectations.
  • Scales up quality operations as required to support EMEA growth, including the establishment of local capability to support the growing organization.
  • Oversees the development and improvement of quality processes that are both scalable and sustainable.
  • Advises on complex projects and the leadership of teams within corporate objectives and project timelines.
  • Manages the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to the appropriate regulations.
  • Develops and implements annual Quality plans, departmental goals, action plans, and budgets.
  • Provides strategies to address compliance gaps and determines enhancements to cross-functional quality systems.
  • Directs and manages the development of Standard Operating Procedures and ensures SOPs are aligned with current practice and controls are established for SOPs and any revisions.
  • Ensures that all manufacturing processes, testing activities, validation activities are performed and documented following pre-defined procedures and protocols.


Requirements

  • B.S./B.A. in a science or related life science field; advanced degree preferred.
  • Must have a minimum of 15 years of experience in medical devices.
  • Minimum of 10 years in a management role
  • Strong knowledge of regulatory standards especially MDD and MDR
  • Experience with the process of EU country registrations
  • Experience with international country regulations beyond the EU is a plus – countries in the greater EEA, Middle East and Africa.
  • Experience with drafting regulatory submissions.
  • Demonstrated knowledge of QMS, including ISO 13485, ISO 14971.
  • Familiarity with IEC 60601 requirements a plus.
  • Self-motivated, team-oriented, and flexible
  • Effective interpersonal skills, ability to guide and influence others.
  • Effective verbal and written communication skills; ability to write clear procedures.
  • Exhibit good problem solving and analytical skills.
  • Exhibit effective project planning and organization skills.

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