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Senior Regulatory Specialist - Medical Devices
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support, Design
Projektbeschreibung
Co-ordinating the preparation and conducting the review of responses to questions raised by the regulatory authorities
Co-ordinating the preparation and conducting the review of Annual Reports and Licence maintenance activities.
People management - lead, coach and develop team members in accordance with Company policies and Procedures.
Customer Service - Support the development of products in a timely manner which meet customer needs, both internal and external, and to high quality standards.
Compliance - Ensure that all work carried out is in compliance with the required standards conforming to Company cGMP, SOP, specifications and Approved Licences Requirements.
AREAS OF IMPACT AFFECTING THE JOB
Licence approval period
Provide product licensing support for and subsidiaries
Maintenance of all product licences
PLANNING, ORGANISING & CONTROLLING
Agree timelines and goals for team, based on Departmental Goals.
Planning on a six monthly basis based on work required.
Management of the day to day activities involved in the regulatory process to ensure high quality dossiers are submitted to the licensing authorities.
CONTACT WITH OTHERS
Manager/Regulatory Specialist
Daily to discuss/propose. suggest solutions to problems
Colleagues within Regulatory
Daily to exchange ideas and be aware of departmental projects/issues. To delegate and ensure that tasks can be performed, to review and re-prioritise if required
Manufacturing
Daily to weekly to discuss proposals for changes to the manufacturing process and to ensure that regulatory changes are made to meet the needs of the manufacturing site(s).
Design
Weekly for preparation/update of artwork for regulatory submissions and product purposes.
Other companies/organisations
Monthly to ensure compliance with contractual agreements.
Portfolio Management
Daily to weekly to provide input through project teams to support the development process.
Regulatory Authorities
As required to address regulatory issues or to seek regulatory advice and to track progression of pending applications
DECISION MAKING AUTHORITY
Self
Interpretation, application and advise on regulatory processes/guidelines
Resolution of queries
Budget
Shared
Review/approve regulatory applications prior to submission
Interpretation and response to deficiency letters
Change control.
KNOWLEDGE, SKILLS AND DIMENSIONS
Minimum Qualifications/Experience
Regulatory experience
Member of TOPRA (The Organisation for Professionals in Regulatory Affairs)
Scientific degree or equivalent qualification(s), or equivalent in terms of substantial industrial experience in EU regulatory affairs.
Knowledge
Working knowledge of regulatory procedures and requirements - European & US
Coaching and supervisory experience
Skills
Excellent verbal and written communication skills
Management and supervisor training
Time and organisation management training
Competencies
Initiative
Analysis/problem solving
Teamwork/collaboration
Tenacity
Diplomacy
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Manchester, Greater Manchester, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges