Director Regulatory Affairs
ProClinical is advertising an exciting opportunity for a position as Director of Regulatory Affairs with a leading medical devices company. Specialising in combining medical devices with biologic materials and cellular therapies, this company is seeking for a talented and hard-working individual to join their team based in Ireland.
The Director of Regulatory Affairs is responsible for the company's regulatory strategy and systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale. The Director will also be responsible for working with sister manufacturers, assisting with communications with relevant authorities, and providing clarification and advice on regulatory requirements. They will also work with the company's senior management team and the global Regulatory Affairs leadership.
- 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 company products are for sale.
- 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 complains are assessed for regulatory reporting, including the associated correspondence to applicable regulatory authorities.
- Providing regulatory support to company functional units, such as CSD, DCM, Engineering, Quality Assurance, and Operations.
- Liaising with regulatory authorities as necessary and appropriate for both pre-market authorisation and post market surveillance activities.
- Acting as Official Correspondent/Contact Person for regulatory authorities as required.
- Meeting and engaging 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 Engineer, 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 submission 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 company senior management team to create a synergistic and cohesive environment.
- Assuming people management responsibilities, including 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 maintaining across all teams within the Regulatory functions, and that all relevant information is cascaded appropriately and in a timely fashion.
- Following local policies and procedures, including but not limited to, health and safety, human resources, travel, and expense reporting.
- Ensuring that the company's Code of Conduct is considered within all business matters carried out on the company's behalf.
Skills and Requirements:
- A bachelor's degree or equivalent, preferably in a life science or chemistry field. An advanced life science degree, such as an MS or PhD, is preferred.
- At least 10 years' experience in medical device regulatory affairs.
- A thorough knowledge of European regulatory environments.
- Strong strategic and analytical abilities, diplomacy, negotiation, and excellent oral and written communications skills; highly organised.
- A proven ability to interact in a group environment, with strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders.
- A thorough understanding of GLV, GCP, GMP, FDA, and ICH guidelines.
- Excellent written and oral communication skills; a detail-oriented work style and the ability to handle multiple tasks.
- An ability to work under pressure and meet deadlines.
- An ability to present fact and recommendations in oral and written form.
- Proficiency with Microsoft Office; additional experience with databases and report writing is a plus.
- A strategic and team building mindset, with good business acumen and a hands-on approach.
- Excellent communication, presentation, and persuasion skills, along with the ability to effectively interact with all levels of the organisation.
- A willingness and availability to travel on company business.
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 call Roberto Esposito on +44 203 761 5702 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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