Senior Regulatory Specialist - Medical Devices

Project Management - Preparation, compilation, review and submission of high quality regulatory dossiers in accordance with EU/US requirements and legislation.

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