Regulatory Affairs Manager
Job Type: Full-time, Permanent
Based: UK but other regions considered
Reports to: Head of R&D
Job Types: Full-time, Permanent
Ultromics is seeking an experienced Regulatory Affairs Manager to develop and manage worldwide regulatory submissions for Ultromics products. The Regulatory Affairs Manager will participate in Core Team meetings and provide direction to the development team regarding global regulatory requirements. The Regulatory Affairs Manager will also support the Clinical Affairs and Research and Development teams in compliance with regulatory requirements for clinical trials. Must be able to think strategically.
Key Duties & Responsibilities
- Responsible for development of worldwide regulatory submissions and technical documentation.
- Provides regulatory support on project teams.
- Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, documentation for changes requiring regulatory approval.
- Ensures overall compliance with international standards and directives.
- Stays current on developments and potential changes and opportunities in global regulatory jurisdictions relating to Ultromics’ products.
- Interfaces with regulatory authorities on regulatory and technical matters.
- Provides regulatory guidance regarding clinical trial regulations and GCP compliance.
- Interprets regulatory guidelines and effectively transfers knowledge to our company policies, clinical studies, testing, engineering documentation and product initiatives.
- Collaborates cross-functionally to ensure regulatory requirements are fully understood for product development strategies and marketing initiatives.
- Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- May perform other duties as required or assigned.
- Desirable: Bachelor’s degree or equivalent, preferably in a scientific discipline or software development
Evidenced by certificates
Skills and abilities
- Ability to be flexible and work effectively with others.
- Must be able to think strategically, and from a Corporate and global perspective.
- Speaks and writes clearly and articulately. Maintains standard in all communications.
- Excellent attention to detail.
- Efficient – able to produce significant output with minimal wasted effort. Must be able to work in a fast-moving environment.
- Listening skills – lets others speak and seeks to understand different viewpoints.
- Negotiation skills – carries out negotiation effectively and maintains relationships while achieving positive outcome.
Evidenced by CV/interview
- Knowledge of regulatory requirements in multiple regions.
- 7+ years of regulatory experience in a medical device company, preferably software experience.
- Experience with clinical trials and clinical trial regulations.
- Desirable: Has worked in a start-up environment
Evidenced by CV/interview
- Works independently and needs little supervision.
- Creative/innovative – generates new and innovative solutions to problems.
- Work ethic – possesses a strong willingness to work hard and sometimes long hours to get the job done.
Evidenced by CV/interview
We are an equal opportunities employer and positively encourage applications from suitably qualified and eligible candidates. Entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
If you’re selected for an interview and have special requirements due to a disability please let us know so that we can make any necessary adjustments.
Information Security Compliance
By applying for this position, you are confirming that you will be required to comply with Ultromics’ Information Security Policies if you are hired for this role.
Ultromics is a global health technology firm which provides autonomous echocardiography analysis through innovative AI solutions – empowering physicians to make fast, accurate decisions when diagnosing cardiovascular disease. We have developed the first and only FDA-cleared fully automated solution for echocardiography and strain analysis. The revolutionary platform, EchoGo Core, is a cloud-based AI service which delivers analysis to any vendor within minutes and with zero variability through its zero-click, full automation workflow.
Our technology was born at the University of Oxford and built in partnership with the NHS and has since raised over £20 million to help bring diagnostic quality to hospitals, improve patient care, and help make valuable resource and cost savings. Cardiovascular disease is the leading cause of mortality, with an estimated 17 million deaths each year. For more information about Ultromics – http://www.ultromics.com/
- Company Events
- Company Pension
- Flexible Schedule
- On-site Parking
- Sick Pay
- Work From Home
- Monday to Friday
How to Apply
Fill in the form below, making sure you attach the following:
1) Your CV
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