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Regulatory Specialist Job

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Date: Nov 18, 2020

Location: Mascot, 14, MY

Company: Boston Scientific

ABOUT THE ROLE

 

<span style="font-family:"Arial",sans-serif">We are seeking an enthusiastic and skilled regulatory specialist to join our ANZ Regualatory Affairs team. This role offers a great opportunity with a global medical device leader to further develop your regulatory skills across a broad range of therapies and technologies.

<span style="font-family:"Arial",sans-serif"> 

<span style="font-family:"Arial",sans-serif">The successful candidate will be responsible for the preparation of regulatory submissions to TGA and Medsafe to ensure timely sumissions , manage existing licences, and maintain compliance to ANZ regulations.  This is a key role in the organisation ensuring physicians and patients have access to the latest medical technologies to enable optimal patient outcomes.

 

<span style="font-family:"Arial",sans-serif">This role will be based in our Malaysian office, supporting the Australia and New Zealand Regulatory team.

WHAT WILL YOU BE REPONSIBLE FOR?

 

<span style="font-family:"Arial",sans-serif">Regulatory Knowledge and Application

<span style="font-family:"Arial",sans-serif"> 

  • <span style="font-family:"Arial",sans-serif">Determine and develop regulatory strategy for submissions
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Compile, prepare, review, and submit regulatory submissions
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Identify issues early in the submission preparation process that could impact product launch, by assessing the acceptability and quality of preclinical and clinical documentation for submission to comply with regulatory requirements
  • <span style="font-family:"Arial",sans-serif">Manage changes to existing products to ensure continued compliance to regulations
  • <span style="font-family:"Arial",sans-serif">Support the review and approval of promotional and advertising materials to ensure compliance with the regulations
  • <span style="font-family:"Arial",sans-serif">Provide postmarket support as required
  • <span style="font-family:"Arial",sans-serif">Liaise with regulatory authorites to negotiate submission details
  • <span style="font-family:"Arial",sans-serif">Mainain information in an internal regulatory database
  • <span style="font-family:"Arial",sans-serif">Provide information for Tenders requests
  • <span style="font-family:"Arial",sans-serif">In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

 

<span style="font-family:"Arial",sans-serif">Business Partnering

<span style="font-family:"Arial",sans-serif"> 

  • <span style="font-family:"Arial",sans-serif">Act as the regulatory contact for assigned divisional regulatory teams
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Communicate and negotiate with regulatory authorities
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Build relationships with divisional regulatory teams to get timely information required for ANZ submissions
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Effectively partner with sales and marketing and operations to develop sound product and business strategies

 

KEY SKILLS & COMPETENICES REQUIRED FOR SUCCESS

 

<span style="font-family:"Arial",sans-serif">Experience and Education

 

  • <span style="font-family:"Arial",sans-serif">An understanding of medical device regulations and quality system requirements
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Bachelors in science or a related degree is desirable
    <span style="font-family:"Arial",sans-serif"> 

<span style="font-family:"Arial",sans-serif">Skills

 

  • <span style="font-family:"Arial",sans-serif">High level of communication skills both verbal and written
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Strong analytical thinking and problem solving skills
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Attention to detail
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Good time management skills
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Ability to plan and prioritise workload
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Ability to work in a team with a collaborative approach
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Demonstrate resilience and perserverance
  • <span style="font-family:"Arial",sans-serif"><span style="font-family:"Arial",sans-serif">Demonstrate adaptability and flexibility

 

<span style="font-family:"Arial",sans-serif">Competencies

 

  • Ability to solve problems
  • Resiliant when dealing with conflicting deadlines
  • Ability to think innovatively and work towards continuous improvement
  • Collaboration
  • Ability to build strong internal and external relationships
  • Remains calm under pressure
  • Accountable for actions
  • Uses a team approach to solve problems and maximise opportunities
  • Infuences outcomes through knowing who to involve and when

Boston Scientific - Advancing Science for Life


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