Medical Device Manager, LCM
Norgine, United Kingdom
Job Description
Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a Medical Devices Manager (LCM) to join Norgine in any Norgine sites. The person holding this position will report to Director Regulatory Affairs LCM.
The Medical Devices Manager is responsible for the lifecycle management of Norgine’s Medical Devices post CE approval, ensuring smooth integration of new products following launch and all associated on-going regulatory maintenance activities. The Medical Device Manager may also support special projects as a subject matter expert, offering knowledge and expertise as required.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
KEY RESPONSIBILITIES amp; ACCOUNTABILITIES
- Maintain up to date knowledge of relevant regulations, guidelines and industry standards and apply in practice through procedures, knowledge sharing and advice to project teams
- Manage liaison and communication with Norgine functions on intentions for changes to the regulatory medical device status, assess internal and external driven change and propose strategies for effective implementation
- Implement agreed regulatory strategies to plan, anticipate and resolve roadblocks, escalate issues through effective communication
- Proactively communicate with relevant internal stakeholders and external contacts to ensure regulatory requirements for submissions are met and approvals expedited
- Ensure preparation, submission and maintenance of high quality documentation, following current best practice standards
- Co-ordinate QMS related regulatory activities e.g. deviations and CAPAs as applicable
- Provide expert advice and support to brand teams and other areas of the business
- Explore opportunities for continuous improvement to enhance business performance
- Maintain data and documentation in compliance with Norgine’s regulatory systems and procedures
- Participate in industry forums
Requirements
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- Must have expertise in the development, certification and maintenance of medical device products
- Effective negotiation and influencing skills
- Proven ability to manage multiple projects efficiently
- Ability to analyse and interpret complex issues and develop strategies and communication plans to resolve
- Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
- Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners
- Shows strong respect and collaborative working with internal and external customers
- Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model.
- Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
- Able to contribute to budget preparation and review
Benefits
Benefits vary between locations.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.
Anti-discrimination and equal opportunities:
· Norgine prides itself on its integrity, honesty and fairness in all aspects of our business. We aim to create a safe, welcoming and engaging workplace.
· Norgine provides equal opportunities to all employees and is strongly committed to the principle of equality regardless of race, religion or belief, age, nationality, sex, disability, pregnancy/maternity, gender reassignment, marital or civil partnership status, or sexual orientation.
· Norgine does not condone any discriminatory acts or attitudes in the conduct of our business between our employees or with external parties. This includes unlawful harassment and victimization.