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Regulatory Affairs Manager job in Cambridge at Inivos Ltd

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Regulatory Affairs Manager at Inivos Ltd

Regulatory Affairs Manager

Inivos Ltd Peterborough, Cambridgeshire, Cambridgeshire Full-Time
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Inivos are looking for a Regulatory Affairs Manager to join the Quality and Compliance team. We promote flexible working as a company, although we are very conscious that this role is likely to be more successful in its delivery where there is a routine of regular attendance to our office in Peterborough or Kings Lynn.

Do you have what it takes to be one of the Inivos team?

We are looking for people who challenge themselves, to set goals, and go above and beyond what is strictly required of them in their role, to achieve these.

Our people passionately strive for excellence which you will see in their careful attention to detail. We are inquisitive and we like to understand, not just for the sake of more knowledge but to fuel our innovation in new products, services, and solutions for our customers. We call this resourcefulness, and a sense that perfection is only just good enough.

We believe that for you to enjoy success in your work, you must apply energy and focus to the tasks you have to do every day. We like to give you the opportunity to stretch yourself beyond your natural ‘comfort zone’ in the knowledge that you will be guided by your inner principles to do the right thing by the business, your colleagues and our customers.

These core values are at the heart of what we do and are easier to feel than to talk about. Show us these and we will enjoy having you on the team at Inivos!

What do we do?

At its core, Inivos is a specialist medical technology business developing, manufacturing, and supplying products and services to enable hospitals and healthcare facilities to reduce the risk of infection.

What are we looking for in this position?

The Regulatory Affairs Manager will report to the Quality and Compliance Manager and will be a key aid to the business. As a Regulatory Affairs Manager you will use your knowledge of the regulatory landscape to ensure products are developed, manufactured, and distributed according to required regulations and standards.

What will you do?

* Maintain product compliance matrix document tracking compliance changes and requirements

* Liaise with external parties (i.e., compliance consultants)

* Ensure products meet regulatory and technical standards

* Demonstrate compliance with global regulations

* Prepare data to obtain certifications and commercialisation authorisations

* Compilation and submission of dossiers and ensuring suitability of product labelling and advertising for all products types in international markets

* Track/report on assigned projects

* Manage relevant technical documentation and files

* Maintain an awareness and ensure compliance with relevant regulations and laws in all markets

* Register products under country-specific requirements

* Act as the regulatory representative in product development teams

* Review processes and procedures

* Identify the need for any regulatory activities

* Attend audits (by both internal and external bodies)

What will you need to have and do?

* Always represent our Core Values: Excellence, Resourceful, Innovation, Understanding and Integrity

* Strong knowledge of scientific, regulatory, and business issues

* Experience with a BPR/MDR background (cosmetic may be considered)

* 3+ years’ experience in a similar role is essential

* Knowledge of European, US and Asian markets is essential

* Knowledge and awareness of the relevant regulatory guidelines and legislation

* Previous experience of ensuring compliance with MDR and BPR

* Excellent knowledge of regulatory frameworks (BPR, MDR, FDA, CE marking, UKCA)

* Experience in International Standards (ISO 13485 & 14971)

* Knowledge of IEC 60601 series

* Knowledge of design control, software lifecycle and risk management processes

* Experience registering biocidal products and medical devices

* Experience with biocidal and medical device approval processes

* Enthusiastic and motivated to work in a fast-paced environment

* Strong communication skills both oral and written

* Organisational skills & developing regulatory project management skills

What will you get?

A competitive salary

25 days holiday + bank holidays

Commitment to your Personal & Professional Development

Contributory Pension

Most of all you will be a part of the Inivos Family, who are a team of motivated and inspiring individuals wanting to play their part in changing the industry and making a difference. Inivos is an equal opportunity employer that is committed to diversity and inclusion in the workplace.

Ready to apply?

Does this role sound like you? Are you the driven, resourceful type who goes above and beyond to get results? Then apply today
 

Recommended Skills

Iso 13485
Iec 60601
Software Development Life Cycle
Risk Management
Project Management
Technical Documentation
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Job ID: 213406516

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