Senior Regulatory Specialist Ftc

5 months ago

Abingdon, United Kingdom Revvity Full time

We are currently seeking a Senior Regulatory Affairs Specialist to join us on a Maternity cover (fixed term contract) of circa 12 months. This position is responsible for Global Regulatory activities within Oxford Immunotec Ltd.

**Role description**

**Overall responsibilities**:

- To assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.
- To provide Global regulatory support to Sales and Commercial teams for ongoing requests for documents and information.

**Specific deliverables for the role are**:

- To work with the Quality Compliance Manager to ensure that verification and validation activities as well as risk management are carried out to support Global regulatory requirements
- To provide support to OI’s facilities to ensure that any regulatory needs are covered. This may include international travel to our subsidiaries
- Assist with the conduct of Internal and External audits to agreed standards, with regard to the regulatory requirements
- To take a central role in the preparation for and implementation of the requirements of global IVD Regulations.
- To take a central role with documentation and regular communication with regulatory authorities to ensure that we are in compliance with their requirements
- To take a central role 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
- Communication with distributors to ensure good relationship management from a regulatory perspective when required
- To assist with the maintenance of OI certification to international quality standards to ensure regulatory compliance (ISO 13485, ISO 17025 and GMP)
- To provide review of sales and marketing documents from the regulatory perspective
- To ensure that any annual administrative regulatory tasks are carried out in a timely manner
- Deputising for either the Regulatory Director or Head of Regulatory Affairs, wherever necessary
- Operate effectively across departmental boundaries to resolve regulatory related issues in collaboration with peer group and other senior managers
- Working to Oxford Immunotec’s Company Values at all times.

**Role requirements**

**Technical skills and abilities**
- Educated to degree level or higher or with a minimum of 5 years relevant experience within IVD/MD Regulatory Affairs
- Good working knowledge of MS programs, the Internet and databases
- Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP
- Substantial previous submissions experience, ideally in a medical device/diagnostics field, and including experience with some or all of US FDA, EU, China NMPA, and Japan PMDA.
- Strong written and oral communication skills
- Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
- Experience in the line management of junior staff
- Experience of the conduct of Internal and External Quality audits
- Ability to operate at 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 mínimal supervision
- 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 co-operative and proactive attitude to other staff, collaborators and senior managers
- Bright, energetic and enthusiastic

**What we offer**:

- Purposeful & inclusive work environment
- Dynamic culture in which customers are at the forefront
- Being part of a highly qualified team that is committed to excellence
- Access to cutting-edge expertise through which you can make positive impact in the world around us

LI-EMEA

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