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Safety Officer & Regulatory Specialist

Employer
Clearline Recruitment
Location
West Sussex, Haywards Heath
Salary
Negotiable
Closing date
7 Nov 2019

View more

Sector
Healthcare
Function
Health & Safety
Contract Type
Permanent
Hours
Full Time

Job Details

Job Title: Safety Officer & Regulatory Specialist

Salary: Competitive salary + discretionary bonus + flexible benefits

Location: Haywards Heath

Our client based in Haywards Heath is looking to recruit a Safety Officer & Regulatory Specialist.

Responsibilities

  • To manage Product Registrations, Maintenance and Extension.
  • Carry out when requested Medical Device Post Market Surveillance.
  • Ensure early identification & trending of Product Complaints.
  • Maintain Regulatory relationships with the external agencies.
  • Management of key relationships with internal parties, Safety Boards, GSS, Business Areas with respect to product safety.
  • Management of the communication of safety issues including company product bulletins and notices.
  • Co-ordinate with the respective business areas to keep abreast of new/changes to products and process developments effecting safety.
  • Identify areas where regulatory & safety input is required for the transition to Services & Solutions.
  • To prepare & carry out any activities required for BREXIT in relation to Regulatory & Safety.

Specific responsibilities

  • Advise on new product and services introductions in regards to regulatory compliance and registrations
  • To keep up-to-date with changes in regulatory, legislations and competent authority guidelines (MEDDEV) and update the appropriate business stakeholders in these developments
  • Advise and monitor parallel importers' activities
  • To map and maintain processes relating to product safety and regulatory requirements affecting the business
  • To build strong relationships with Global Safety Officers and other key stakeholders
  • Ensure appropriate cover for safety issues through the Deputy Safety Office
  • Communicate and liaise with UK and Irish regulators/Competent Authorities as well as regional EEA representatives on product safety and vigilance issues including review and submission of Initial, Follow-up and Final Trend Reports
  • Discuss observations of safety issues with managers and/or global Quality and Vigilance Teams, recommend and drive any corrective actions necessary
  • Manage local product complaints (UK and Ireland) and advise both global and local Leadership teams
  • Draft and issue investigation reports to regulators and other stakeholders such as Healthcare professionals, patients and coroners
  • Manage field safety corrective actions (FSCA's) including recalls and regularly reporting to Competent Authorities, regional vigilance and safety board teams
  • To convene and chair UK Safety Board Meetings and ensure suitable plans are in place to effectively action, monitor and conclude Product Safety Issues affecting to UK and Ireland
  • To work with the Global vigilance, Safety Board and Quality members to ensure that any product safety issues are properly managed and processed in accordance with regulations and company standards and implement corrective and preventive actions
  • To liaise with Marketing and Product managers to ensure that any product safety issues are properly escalated in accordance with regulations and company standards
  • To ensure that the Product Safety Case Register is maintained and updated alongside organizing associated files on a regular basis
  • To map and maintain processes relating to product safety and regulatory requirements affecting the business
  • Work with Medical Affairs to review product literature (Manuals, patient leaflets), labelling and promotional materials to ensure correctness of content
  • Advise on new strategies to offer added value services to both existing and new streams
  • To represent the UK and Irish affiliate at regional and global Regulatory/Quality meetings and feeding back to the Leadership Team on new developments
  • Assess customer feedback and reporting trends to the Leadership Team
  • Issue reports (trend analysis of complaints) to the Leadership Team and recommend corrective and preventative actions
  • To be involved in projects, including those using agile and lean methodology at the request of line manager
  • To demonstrate a high sense of personal responsibility with proven ability to manage challenging priorities whilst meeting deadlines and remain flexible and adaptable
  • To provide training support to existing team members and new starters as requested by line manager
  • In conjunction with line management, to initiate and act upon a personal development plan
  • Maintain Job description to ensure it reflects current responsibilities and role requirements

Requirements

  • University Degree or equivalent
  • Previous proven experience working for an international company in Quality/Regulatory operations
  • Proven experience in working directly with Registered Bodies and the MHRA/HSE
  • Highly organised with proven strong communication skills at all levels
  • Proven ability to influence and drive change
  • Self-motivated with a passion for achieving results
  • Flexibility to travel - this role may require some travel

Desirable:

  • SAP experience
  • Experience working with the Google suite of programmes

For more information please contact Angela Potter at Clearline Recruitment.

Company

Clearline Recruitment; a full-service recruitment consultancy specialising in Commercial Recruitment across Brighton, Hove, Crawley, Worthing, Eastbourne, Hastings, Horsham, Bexhill and the wider Sussex areas.

Clearline Recruitment offers high calibre advice on best practice recruitment‚ job descriptions‚ interview techniques, candidate support and specialist head hunting. Our team has built a strong reputation for recruiting in-demand talent for organisations of all sizes.

Company info
Telephone
01273 063769
Location
Fourth Floor
132 Queens Rd
Brighton
BN1 3WB
GB

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