We are growing, grow with us!
PharmaLex has created this exciting new opportunity for an experienced professional to join our growing team in the UK and Ireland.
PharmaLex is one of the largest providers of development consulting, regulatory affairs, quality management & compliance and pharmacovigilance services worldwide. Our global teams of experts lead clients through early stage strategic planning activities, non-clinical requirements and clinical development, regulatory submission processes and finally guide them to market approval, after which our support extends into product maintenance activities. As a global organisation with over 31 offices in 17 countries, our reputation, client-base and international footprint continue to grow, making it a very exciting time to join PharmaLex. With excellent local and international collaboration, the associated project work is diverse and rewarding.
The successful candidate will have accountability for the execution of projects in the field of Regulatory Affairs that require established experience and specific scientific expertise in the relevant regulatory requirements for Medical Device registrations and maintenance activities in major markets, particularly in Europe.
Senior Manager - Regulatory Affairs, Medical Devices
- Contribution to regulatory affairs, development consulting and scientific affairs programmes and projects, ensuring that they are delivered to a high standard.
- Provision of regulatory expertise to regulatory programmes and projects being managed by PharmaLex UK and other international PharmaLex offices.
- Provision of general guidance (consultancy) to PharmaLex staff and customers regarding the different classes of Medical Device and the device registration procedures (particularly CE marking) in major markets.
- Provision of general guidance (consultancy) on the requirements of the new Medical Device Regulations and impact on Medical Devices of the Medical Device Directive.
- Interdisciplinary project work regarding the strategic orientation of new medical devices for global markets.
- Coordination, writing and approval of technical documentation for medical device product approvals.
- Management of communications on behalf of clients with Notified Bodies / Health Authorities and other external parties involved in the registration or ongoing maintenance activities for Medical Devices.
- Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients to ensure medical device labelling compliance.
- Presentation at seminars and lectures on behalf of PharmaLex, for customers and professional audiences.
- Creation, revision, editing and maintenance of regulatory documentation.
- Planning and expediting of projects using the internally available or client-based software tools.
- Professional interaction with clients, Notified Bodies and Health Authorities.
- Coordination of project teams with internal / external staff and Regulatory Alliance Partners.
- Contribution to optimizing departmental internal processes.
- Participation in strategic regulatory issues.
- Compliance with clients’ budgetary expectations.
- Provision of technical support to business development activities.
- Accurate time reporting.
- Technical support for business development.
- Experience working across the different classes of Medical Device (I, II(a), II(b) and III) within a relevant industry environment
- Knowledge of medical device regulatory affairs throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labelling, Change Control, Commercialization, and Operations
- Regulatory experience with other product types such as pharmaceuticals (medicinal products), cosmetics or nutritional products would be an advantage.
- Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labelling regulatory activities for assigned devices
- Ability to translate strategic goals of partnerships/customers or internal projects into tactical goals and implement concrete milestones; ability to define appropriate escalation processes
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly; and conclusions adequately supported by data
- Ability to lead extensive project re-engineering activities and provide consultation related to change management
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
- Ability to proactively identify and follow up on prospective business opportunities
- Ability to manage complex projects with problem solving and a strong understanding of the business
- Capability of supervision, prioritisation and processing of parallel projects and tasks
- English language fluency, with strong written and spoken communication skills with internal and external customers, colleagues and supervisors
- Good presentation skills
- Structured, analytical, systematic and independent manner
- Excellent team player
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- University degree in pharmacy or other natural sciences
The position can be based in our office in Bourne End, Buckinghamshire, Redruth, Cornwall, or in Portmarnock, Co. Dublin. Given the nature of the role, some UK and international travel can be expected.
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please use the "apply now" button below
Agencies only by prior agreement for the specific job opportunity.