Regulatory Affairs Officer

6 months ago

Woodstock, United Kingdom Owen Mumford Full time

Owen Mumford is looking to hire a Regulatory Affairs Officer to join the team Could this be your next role?

As a Regulatory Affairs Officer you will review and manage all technical files within the timelines schedule as well as identify applicable regulatory requirements to facilitate product registrations, advise with supporting internal & external customers on these requirements and opportunities.

**Key Responsibilities**:

- Maintenance and review of new and existing technical files including performing periodic reviews and update of clinical documentation.
- Assist Sales & Marketing team for labelling to be compliant with Regulatory Affairs and MDR requirements.
- Manage, prepare and collate required documentation to support submissions for product approval and maintenance (e.g. Variations to Marketing Authorisations, FDA 510K), NDA/BLA etc)
- Develop & maintain processes to register new devices within applicable Regulatory System e.g., EUDAMED/GUDID.
- Manage the creation and development of technical dossiers for products in compliance with applicable local regulations to gain approval to commercialise products in any markets required by OM Ltd.
- Primary contact responsible for Free Sales Certificate orders/ legalizations and notarizations with timelines schedule
- Review & approve proposed marketing materials, packaging, Instructions for Use and Label copy for Regulatory compliance to Annex I for CE marked devices and to the appropriate requirements for ROW markets
- Manage, prepare and collate required documentation to support submissions for product approval and maintenance (e.g. Variations to Marketing Authorisations, FDA 510K), NDA/BLA etc)
- Manage the creation and development of the portfolio of Technical Dossiers and licences to support market registrations
- Work with customers and internal SMEs to assure the continued Regulatory Compliance of existing products throughout their life cycle

**To be successful in this role, you will need**:

- Minimum 5 years’ experience of worldwide medical device market experience and/or in vitro diagnostic devices (working with Class I, II or III Devices).
- Experience of controlled drug/cold chain licensing
- Experience in drug submission creation or drug submission support
- Medical Devices Directive (93/42/EEC) and /or the IVD Directive (98/79/EC) and MDR
- ISO 13485
- Excellent written and oral skills
- Excellent interpersonal skills with an ability to work on their own initiative and as part of a multi disciplinary team.
- Basic computer literacy - Excel, Word, Powerpoint.
- A self-motivated individual who can ensure that required tasks can be completed with mínimal supervision
- A confident individual with excellent attention to detail. Well presented and personable.

**What will we give you?**

You will be joining a successful, privately owned industry leader who are constantly innovating and looking to improve lives, empower patients and relieve the pressure on healthcare professionals. We invest heavily in our staff and offer a competitive salary and benefits package along with the opportunity to develop within the business. Additional benefits include:

- Remote working - up to 2 days per week
- Flexi time - covering 37.5 hours per week with core working hours of 9:30am-12 Noon and 2:00pm-4:00pm (3:30pm on Fridays)
- 25 days annual leave (with the opportunity to earn loyalty days with length of service)
- Holiday purchase scheme (up to 10 days purchased per holiday year)
- Enhanced Family Friendly Policies
- Enhanced Sickness Pay
- Group Life Insurance
- Wellbeing initiatives and support
- Annual company bonus
- Free parking, free tea & coffee and free fruit

**About us**:
Owen Mumford is a global leader in medical device design and manufacture. For almost 70 years we have been inventing life-enhancing devices that are tested and proven to deliver an industry benchmark in the safety, accuracy and comfort of medication administration. This strong heritage is the springboard for our future as we help to shape the progress of the healthcare industry by bringing pioneering concepts and solutions to life in an accountable and sustainable way. Headquartered in the UK, Owen Mumford is a family-run business with a large global presence across North America, EMEA and APAC.

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