Director of Regulatory Affairs

Scope:

The Director of Regulatory Affairs is responsible for leading the regulatory team, regulatory strategy, systems, and ensuring that the company’s products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable. The Director of Regulatory Affairs is also responsible for working with sister manufacturers, to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements. Taking global functional direction, the Director of Regulatory Affairs is a member of the senior management team and the global Regulatory Affairs leadership team.

Responsibilities

  • Direct, mentor and lead the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals and objectives.
  • Ensure the outputs from the individual functional units (engineering, marketing, clinical, clinical communications etc.) meet the applicable marketing authorisation requirements as necessary.
  • Liaise with regulatory authorities as necessary and appropriate for both pre-market authorisation and post-market surveillance activities.
  • Work with regulatory groups locally and globally to develop and implement strategies for the most efficient and timely submission and approval of regulatory filings.
  • Provides regulatory support to functional units such as CSD, DCM, Engineering, Quality Assurance and Operations.
  • Liaise with regulatory authorities as necessary and appropriate for both pre-market authorisation and post market surveillance activities.
  • Official Correspondent/Contact Person for regulatory authorities as required.
  • Meet and engage with regulatory authorities (Competent Authorities, Notified Bodies and global regulatory agencies as required) to understand their needs and expectations.
  • Develop and advise on regulatory strategies for new, existing and changing products in collaboration with Engineering, Quality Assurance, Divisions, clinical and other stakeholders as appropriate.
  • Work with regulatory groups locally and globally to develop and implement strategies for the most efficient and timely submission and approval of regulatory filings.
  • Identify and monitor legislative and regulatory activities and report their potential impact on the company to local and global leadership as necessary.
  • Ensure compliance to global policies, procedures and direction.
  • Manage regulatory costs and ensure a full understanding of departmental expenditure and budget.
  • Provide mentorship, coaching and support to direct reports and act as a point of escalation where necessary for specific issues that may arise.
  • Ensure open communication channels are maintained across all teams within the Regulatory function, and that all relevant information is cascaded appropriately and in a timely fashion.
  • Seek out continuous improvement best practice with an emphasis on what can be learned and implemented to drive a best in class operation and efficient processes.

Qualifications:

  • Bachelor’s degree in life sciences or chemistry. An advanced life science degree (e.g. MS, PhD) is preferred.
  • Minimum of 10 years’ experience in medical device regulatory affairs.
  • Solid working knowledge of European regulatory environment.
  • Thorough understanding of GLP, GCP, GMP, FDA and ICH guidelines.
  • Excellent written and oral communication skills; a detail-oriented work style and the ability to handle multiple tasks.
  • Must be able to work under pressure and meet deadlines.
  • Proficient use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
  • Must be a strategic team builder with good business acumen, combined with hands-on approach.
  • Willingness and availability to travel on company business.

To discuss the role or to request an information pack please contact Anthony Carrig, InterSearch Ireland – Anthony@intersearch.ie 

To apply for this job email your details to anthony@intersearch.ie.

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