Regulatory Affairs Associate

Location: Cardiff

Contract Type: Permanent Full Time

Closing Date: 18 June 2021

Salary: Competitive

Regulatory Affairs Associate

ABOUT THE ROLE

Reporting to the Regulatory Affairs Manager, Regulatory Affairs Associate will provide support to the Regulatory Manager on matters crucial between the UK Businesses of Respond Healthcare, Pelican Healthcare & Eakin Surgical, their products and regulatory authorities.

 

KEY ACTIVITIES

  • Ensure the UK Businesses products comply with regulations of the regions where they are and wish to be distributed.
  • Keep abreast and communicate updates on any national or international legislation or guidelines.
  • Support the Regulatory Affairs Manager with regards to liaising with Notified Body and Competent Authority.
  • Support the Regulatory Affairs Manager with logging and trending of complaints.
  • Support the Regulatory Affairs Manager preparing submissions for registration into new markets.
  • Support the Regulatory Affairs Manager preparing Product submissions and Certification Renewals.
  • Support the QARA team and UK Businesses at all external agency and customer inspections.
  • As a member of the UK QARA team, develop and implement a system for imbedding a QARA culture through the UK Businesses.
  • Responsible for ensuring the UK Businesses Quality Management System reflects requirements and is kept compliant.
  • Provide Regulatory support for Commercial & Marketing departments on matters such as product label, packaging and literature guidance.
  • When required, support projects to enable NPI in line with agreed timelines.

Other

  • To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
  • To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
  • To adhere to the company’s Quality policy and Environmental policy
  • To undertake other duties as may be reasonably required

 

KEY SKILLS 

Essential

  • Educated to GCSE Level
  • Proven experience within a regulatory affairs environment
  • Strong Communication skills, both verbal and written
  • Organised with an ability to assess priorities and deliver.
  • Ability to work as part of a team
  • Competent In the use of relevant Microsoft packages
  • Experience working within an ISO standard and FDA 21CFR regulated industry
  • Methodical with analytical and problem solving skills

Desirable

  • Full UK driving License
  • Experience within a Regulated Medical Device Company

 

KEY WORKING RELATIONSHIPS

Internal

  • Quality, Manufacturing and Supply Chain, Engineering, Eakin Research & Development

External

  • Suppliers
  • Notified Bodies & Competent Authorities

 

COMPETENCIES

Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.

Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.

Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail.

Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.

Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively.

Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.

 

Apply now