Senior Regulatory Affairs Associate

Job content

Reporting to the Head of Regulatory and Clinical Affairs, the Senior Regulatory Affairs Associate will be responsible for the preparation and maintenance of global regulatory submissions in accordance with the business strategy and objectives. The successful candidate will assist in the assessment of the regulatory impact of product and process changes and provide input to the planning and roll-out of changes to registered products. The role holder will proactively identify and interpret new implementing acts, guidance, and standards.

Key aspects of the role

· Responsible for the preparation of technical documentation and submission of global regulatory filings for example MDR, PMA applications, supplements

· Ensures that all regulatory requirements are met for the markets concerned

· Develops regulatory strategies for new products to ensure seamless launch to the market.

Applicant requirements

· The candidate will be educated to BSc level in a technical or scientific discipline

· possess relevant post-academic experience within medical devices, IVD, or pharmaceuticals

· a solid understanding of EU and other international regulatory requirements.

· excellent written and verbal communication skills.

· organised and able to work to tight deadlines with superior attention to detail

· the successful candidate will be used to reading and interpreting regulatory guidance documents, and able to grasp and convey complex scientific or technical information.

Desirable

· Knowledge of filing PMA or 510(k)s and supplements

· Class III medical devices experience a distinct advantage.

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.

At this stage we can only consider candidates with the right to work in UK. If you are not contacted by our HR team within 7 days from the closing date, you will not have been successful on this occasion.

Please note, we do not accept unsolicited calls from agencies as Hyaltech Ltd., has selected recruitment partners already in place.

Application deadline: 03/08/2021

Job Types: Full-time, Permanent

Salary: £40,000.00-£46,000.00 per year

Additional pay:

• Quarterly bonus

Benefits:

• Bike to work scheme
• Flexible schedule
• On-site parking
• Work from home

Schedule:

• Monday to Friday

Work remotely:

• Temporarily due to COVID-19