Director, Regulatory Affairs - Medical Devices - EMEA
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Director, Regulatory Affairs (Clinical and Medical Device Regulatory Submissions)
Home or office based, EU wide
The Role:
Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.
Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments.
Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organisation as required.
Manage workflow including prioritising project objectives and establishing timeframes for projects with clients and managing client contracts.
Effectively prioritise and complete multiple projects within established timeframes and within budget
Train, coach, and develop assigned individuals to build overall team expertise
Develop and implement strategies and regulatory submissions for IDE/CTA/ITA submissions, Pre-Submission Requests, Breakthrough Designations, 513g Submissions, 510(k) Submissions, DeNovo Submissions, PMA submissions and Scientific Validity Reports
Manage the creation of a range of clinical documents including: Clinical protocols, Master Informed Consent / Assent, Investigator Brochures, Clinical Study Reports, Clinical Study Summaries, Clinical Evaluation Reports, Clinical Evaluation Plans, Clinical Development Plans, Literature Reviews
Function as primary liaison with regulatory agencies for designated projects and designated clients
Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients.
Act as scientific thought partner with the client and the project team throughout the project.
Initiate and nurture client relationships and maintain contacts to build reputation.
Speak at conferences and webinars, as appropriate.
Knowledge/Skills/Attributes
Thorough working knowledge of local and global medical device Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
Effective project management skills
Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat. Knowledge of Google Suite Apps (Docs, Slides and Sheets) would be an asset.
Ability to make decisions independently and operate autonomously
Sound listening, conflict management, and negotiating skills
Excellent planning, organisation, interpersonal, time, and change management skills
Demonstrable good problem solving, judgement, and decision-making skills
Ability to develop and maintain excellent rapport with clients
Highly motivated and proactive
Knowledge of business development process
Outstanding verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding
Confident and competent when interacting with varying levels of management: stays focused and on-point, is able to raise problems in a productive and mature manner
Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.
Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
Experience in client interaction and/or in a consulting environment is advantageous
Education/Experience:
Bachelor’s degree in a relevant discipline, preferably in life sciences, or other healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field is an asset.
Clinical background or knowledge (this will be important to be able to manage creating some of the clinical documentation)
Expert level experience in Regulatory Affairs knowledge within the setting of a Medical Device, CRO or Independent.
Proven experience and effectiveness leading strategic regulatory activities for product development from entry into man through lifecycle management.
Experience participating in global product development teams: has excelled in cross-functional teams
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
