Regulatory Affairs Director

ProClinical is advertising a vacancy for a Regulatory Affairs Director position with a leading management consulting company. The organisation works with medical device companies to solve quality and regulatory compliance challenges, whilst also providing support for Lean Quality Systems, Interim Leadership, and Talent Acquisition. Based in Ireland's Munster Province, this is an exciting opportunity to work with a company that is driven by the success of its clients.

Job Responsibilities:

• Directing, mentoring, and managing the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals and objectives.
• Ensuring the regulatory systems and procedures meet the necessary regulatory requirements pertaining to company registration and product marketing authorisation where products are for sale.
• Ensuring the outputs from the individual functional units (engineering, marketing, clinical, clinical communications, etc) meet the applicable marketing authorisation requirements as necessary.
• Ensuring that company products are appropriately registered and maintained in all countries where they are for sale - managing and maintaining country restrictions as necessary.
• Ensuring that company products are appropriately registered and maintained in all countries where they are for sale - managing and maintaining country restrictions as necessary.
• Ensuring that complaints are assessed for regulatory reporting including the associated correspondence to applicable regulatory authorities.
• Providing regulatory support company functional units, such as CSD, DCM, Engineering, Quality Assurance, and Operations.
• Liaising with regulatory authorities (Competent Authorities, Notified Bodies, and global regulatory agencies as required) to understand their needs and expectations.
• Developing and advising on regulatory strategies for new, existing, and changing products in collaboration with Engineering, Quality Assurance, Divisions, Clinical, and other stakeholders as appropriate.
• Working with regulatory groups locally and globally to develop and implement strategies for the most efficient and timely submissions and approval of regulatory filings.
• Identifying and monitoring legislative and regulatory activities and reporting their potential impact on the company to local and global leadership as necessary.
• Ensuring compliance to global policies, procedures, and direction.
• Managing regulatory costs and ensuring a full understanding of departmental expenditure and budget.
• Contributing and working as part of the senior management team to help create a synergistic and cohesive environment.
• Undertaking people management responsibilities to the direct reports to this role, including but not restricted to, generating training and development plans, carrying out performance appraisals, and dealing with performance related issues.
• Providing coaching and support to direct reports in their day to day roles and acting as a point of escalation where necessary for specific issues that may arise.
• Ensuring 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.
• Seeking out continuous improvement best practice with an emphasis on what can be learned and implemented at Cook Ireland to drive efficient processes.
• Following local policies and procedures, including but not limited to, health and safety, human resources, travel, and expense reporting.

Skills and Requirements:

• 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.
• Demonstrable multitasking, project management, and execution skills.
• Willingness and availability to travel on company business.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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