Regulatory Affairs Manager (IVD/Medical Device)
Accenian are working with an IVD business who are looking to hire a Regulatory Affairs Manager with expert knowledge within the in vitro Diagnostics industry and of managing/leading RA teams.
This role will help support effective management of the organisation's regulatory affairs strategy, in order to support and fulfil the company's global commercial strategy. The role requires management and liaison with the senior management team, internal team functions, regulatory authorities and company partner organisations.
Key Areas Of Responsibility
Managing a small RA team covering all areas of regulatory support for the business Lead the creation, management and maintenance of Technical Files / Medical Device Files for the company product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities.
Manage and lead the IVDR planning transition for the business.
Experience of country approval (e.g. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support.
Lead and support the preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities.
Proactively manage relationships and communications with regulatory agencies and authorised representatives.
Maintain a high level of specialist knowledge of the regulatory requirements within each of operational geographical territories.
Manage the collation, interpretation and dissemination of specialised regulatory information across the business.
Generate the development of the company's regulatory plan, incorporating strategies for the product range in accordance with global requirements.
Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business.
A degree in Life Sciences, either in genetics or molecular biology.
Significant experience of working within IVDD regulatory affairs.
Evidenced experience of successfully managing/leading an RA team.
Knowledge of ISO 13485 and IVD Directive requirements.
Knowledge/application/training of the IVD Regulations. Knowledge/application of EU harmonised standards associated with IVDS.
Excellent organisational skills and an ability to work to tight timelines. Demonstrates excellent/strong team skills.
The role of the Regulatory Manager will be a permanent opportunity.
Salary: £60,000 – £70,000 base, plus benefits.
Flexible working options (3 days on site) – Client based in Manchester
Manchester, Greater Manchester
Offerd Salary0- £15,000