Job Title: Regulatory Manager

Reporting to: Head of Regulatory Affairs

Location: Milton Park, Abingdon

Responsibilities:

• Supervise and manage global regulatory activities.
• Assist the Head of Regulatory Affairs with the company's regulatory process leading to timely product approval for both new and existing products.
• Assist the Quality team in the management and continuous improvement of the company's Quality Management System as it relates to regulatory activities in compliance with regulatory requirements.
• Provide global regulatory support to Sales and Commercial teams for ongoing requests for documents and information.

Specific Deliverables:

• Provide support to the company's facilities to ensure that any regulatory needs are covered. This may include international travel to subsidiaries.
• Assist with the conduct of internal and external audits to agreed standards, with regard to the regulatory requirements.
• Take a central role in the preparation for and implementation of the requirements of the IVD Regulations.
• Assist with documentation and regular communication with regulatory authorities to ensure that the company is in compliance with their requirements.
• Assist with the provision of regulatory affairs input to research and development programs in order to ensure that these programs deliver products that are capable of early product approval by regulators.
• Communicate with distributors (including other group companies) to ensure good relationship management from a regulatory perspective when required.
• Assist with the maintenance of the company's certification to international quality standards to ensure regulatory compliance (ISO 13485 and GMP).
• Ensure that any annual administrative regulatory tasks are carried out in a timely manner.
• Deputize for the Head of Regulatory, wherever necessary.
• Operate effectively across departmental boundaries to resolve regulatory related issues in collaboration with peer group and other senior managers.
• Work in accordance with the company's values at all times.

Qualifications:

• Educated to degree level with a minimum of 5 years relevant work experience.
• Good working knowledge of MS programs, the Internet and databases.
• Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP.
• Good working knowledge of MDSAP.
• Strong regulatory experience within the diagnostics and or IVD field with previous submissions experience in a range of territories including but not limited to US, EMEA, and APAC.
• Strong written and oral communication skills.
• Good understanding of the scientific, biological and technical issues involved in developing diagnostic assays.
• Strong people management skills.
• Experience of the conduct of internal and external quality audits.
• Ability to operate at senior manager level and demand respect of peer group.

Emotional Skills and Abilities:

• Ability to think analytically, to solve problems and identify solutions.
• Ability to work with minimal supervision.
• Excellent attention to detail.
• Ability to continue to learn new skills and adapt to new ideas.
• Excellent interpersonal skills employed to communicate with individuals on all levels and from different areas of the business.
• Ability to manage people effectively.
• Team working profile with a cooperative and proactive attitude to other staff, collaborators and senior managers.
• Bright, energetic and enthusiastic.