Regulatory Specialist

Location UK / Belfast

Job Type Not disclosed

Salary Not disclosed

Updated 4 days ago

Reference 1438500

 Job Description

Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards.

 

The RA Specialist will be responsible for the following activities:

Supporting interpretation of MDSAP and EU-MDR

Supporting the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR

Providing inputs to the project manager and Snr RA Specialist to support the creation of project plans for MDSAP and EU-MDR

Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with MDSAP and EU-MDR

Conducting updates to labelling, SOPs, work instructions and policy documents to ensure compliance with Stryker corporate SOPs

Supporting internal and external audits as required

Supporting regulatory submissions and registrations as required Managing the regulatory team on a day to day basis

Supporting creation of Quality Agreements as required

  • Identifies information sources and resources for local, regional, and global regulations
  • Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information
  • Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
  • Provides information used to evaluate proposed products for regulatory classification and jurisdiction
  • Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities
  • Assists in the development of regulatory procedures and SOPs
  • Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations
  • Organizes materials from preclinical and clinical studies for review and assists in the review process
  • Compiles and organizes materials for pre-submission reports and communications
  • Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
  • Tracks the status of applications under regulatory review and provides updates to the regulatory team
  • Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
  • Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings

 

Qualifications:

Level 6 qualification in Engineering, Science, or related discipline; or MS in Regulatory Science

  • Experience:

Experience within a regulated environment preferred

  • Specific Knowledge

Coordinate and support technical and scientific regulatory activities. 
Under supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.
Some evaluation, originality or ingenuity is required. 
Clearly conveys information to peers, supervisors, and other stakeholders
Assists in the preparation for meetings with regulatory agencies and other stakeholders
Assists in the preparation of briefings and other information documents
Communicates information on regulatory requirements to other departments and business units
Composes routine communications with regulators and other key stakeholders
Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace
Connects and relates well with people who think and act differently than oneself
Embraces scrutiny and accepts feedback as opportunity to learn and improve

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position

     Time management skills, writing, coordination, and execution of basic regulatory items.