Regulatory Affairs Associate I

1 month ago

Livingston, United Kingdom Hyaltech Ltd. Full time

**Role Profile**

As a Regulatory Affairs Associate, you will assist the regulatory team to obtain and maintain the necessary certificates to sell our medical devices in most countries around the globe. Reporting to the Senior RA Associate, you will work with our global team to prepare product labelling, technical and administrative documents and answer varied queries.

**Key aspects of the role**
- Supporting the launch of new products as well as expansion of existing products into new territories by compiling, sending and tracking technical documentation
- Helping to respond to regulatory queries from customers and authorities
- Reviewing and creating product labelling to ensure it meets international requirements
- Sending and tracking assessments for product and/or manufacturing process changes and collating responses.
- Making administrative updates to maintain product technical documentation.

**Applicant requirements**
- Recently achieved or on track to receive at least BSc level in a technical or scientific discipline
- Willing to learn and develop knowledge with a genuine interest in a career in the medical sector.
- Excellent written and verbal communication skills, in particular with good attention to detail.
- Organised and able to work to tight deadlines
- Understands the importance of discretion in the handling of sensitive and confidential information

**Desirable**
- Previous work experience in any regulated business.

**About Hyaltech Ltd**
Hyaltech is a leading manufacturer of hyaluronic acid injectables used in ophthalmic & orthopaedic medical procedures. The company holds itself to the highest standards of integrity, quality, and excellence. Being an ISO 13485 approved company,

Hyaltech Ltd. has contributed to the healthcare industry for over 25 years.

**About ZEISS**
With over 25,000 employees, ZEISS is one of the global leaders in the optical and optoelectronic industries and has been contributing to technological progress for over 165 years. ZEISS develops and distributes lithography optics, measuring technology, microscopes, medical technology, eyeglass lenses, camera, and cine lenses, binoculars, and planetarium technology.

**Job Types**: Full-time, Permanent

**Salary**: £23,000.00-£26,000.00 per year

**Benefits**:

- Company pension
- Flexitime

Schedule:

- Flexitime
- Monday to Friday

Supplemental pay types:

- Bonus scheme
- Quarterly bonus

Ability to commute/relocate:

- Livingston: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Regulatory Affairs: 1 year (preferred)

Work Location: In person

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