Regulatory Officer

3 months ago

Edinburgh, United Kingdom i4 Product Design Ltd Full time

**About i4PD**:
i4PD is an employee-owned product design and development consultancy. The firm is an established brand in Scotland with an excellent reputation for delivering cutting edge designs for its clients. The company employs creative designers and experienced engineers who operate out of i4PD’s bright and spacious studio on the south side of Edinburgh. The team work collaboratively with clients to augment their internal capabilities and availability to deliver excellent results, faster.

**Role**:
i4PD are undergoing an exciting period of growth. You will join our existing regulatory team here at i4PD to support multi-disciplinary projects involving product design, mechanics, electronics and software. With a continual focus on quality, you will liaise not only internal teams but our clients and engineering partners to support full-lifecycle product development. Your client engagement skills will be honed to enable you to define clients’ regulatory strategy and compliance requirements in order to bring a project through gold standard design & development in line with ISO 9001 & ISO 13485 and set them up for future certification.

**Reporting**:
Your line manager will be the Regulatory Lead.

**Responsibilities**:

- Following the company's QMS to ISO 9001 & ISO 13485 as applicable.
- Maintaining your knowledge in the regulatory compliance industry.
- Analysing project briefs, identifying and clarifying issues for the creation of project proposals.
- Providing guidance to i4PD personnel, clients, and stakeholders on regulatory aspects of the project as required.
- Drafting, signing and delivering regulatory documentation as required by the project plan including regulatory strategy reports.
- For communicating with clients: presenting deliverables, challenges, risks on regulatory aspects of the project as required.
- For supporting or chairing workshops relating to the project plan as required.
- Leading discussions with test houses.
- Alerting team leads/PMs to requests from customers that were not part of scope of work assigned.
- Capturing project change requests and assisting with assessment of regulatory impact.
- Financial administration with regards to regulatory aspects of the project as required.
- Contributing to continuous improvement of the regulatory team and the quality of their output.

**Essential Functional Skills and Experience Requirements**
- Form a key part of our product design & development team, coordinating compliance activities within our projects alongside our clients and internal i4PD personnel.
- Ensure that work carried out by yourself and the i4PD team is conducted to a consistent and high standard in accordance with our ISO 9001 & ISO 13485 Quality Management System.
- Have minimum 3 years’ experience within medical device, machinery, low voltage, electromagnetic compatibility regulations/directives across territories such as Great Britain, Europe and USA.
- Produce or assist in the production of high quality, accurate compliance documentation, demonstrating organisation and traceability through our development projects.
- Have strong communications skills, able to guide your project team members, clients, and stakeholders through compliance processes and requirements in a clear and concise manner.
- Have familiarity with standards, tasks and documentation required to meet risk management processes, usability engineering and software development along with other typical standards for medical and electronic device development.
- Have experience working on your own and with multi-disciplinary teams and be able to demonstrate a deep understanding of how projects should be planned, organised, and executed as you will be managing compliance tasks with your own projects with budgets & timelines, preparing proposals and supporting business development activities.
- Need to demonstrate that you are personable and approachable to both clients and our internal team alike. You should be able to listen to others and respond to their questions or concerns in a way that makes them feel heard and that improvements/feedback is implemented as required.

**Personable Attributes**
- Personable and engaging.
- Excellent communicator (both verbal and written).
- Self-motivated with excellent problem-solving skills.
- Enthusiastic about learning and keeping up to date with the latest industry developments
- Detail-oriented with a high level of accuracy.
- The ability to manage your own time on assigned projects.

**Package**

This is a superb opportunity to join a forward thinking and successful employee-owned SME business. In return you can expect a highly competitive salary & company workplace pension within a challenging and supportive culture and the opportunity to grow your career.
- Industry competitive salary. £25-30k full time or pro-rata for part-time.
- Enhanced 10-week full Maternity Pay / 4 week full Paternity Pay.
- Full time employees receive 30 days holiday (including p

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