Our client, an International Company, dealing with the provision of solutions in energy, healthcare, transportation and finance is seeking to recruit a Regulatory Affairs Support.
The Regulatory Affairs Support – Region may be involved in Pre or Postmarket duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure the
Organization Health Care establishes and implements best practice processes and procedures in premarket and post market support.
- He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country
- Bachelor’s Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy
- Minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
- Experience in a medical device or pharmaceutical industry
- Strong analytical skills
- Ability to work in a team environment with minimal supervision on projects and activities
- Ability to prioritize, plan & evaluate deliverables
- Knowledge & experience conducting scientific, regulatory, legal, or business research.
- Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
- Experience using spreadsheet and presentation software
- File and maintain regulatory deliverables
- Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
- Support regulatory inspections as required
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and post market reporting through the development, maintenance and improvement of documented processes.
- Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
- Communicate with Product RA to establish regulatory requirements, including clinical trial data.
- Complete specific country testing and work with Product RA; arrange for test devices and support as needed.
- Provide RA oversight to clinical studies to ensure regulatory requirements are met
- Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required.
- Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
- Work with Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license
- Monitor external information for incidents or issues that may involve the organizations Health Care products; communicate information internally in a timely manner.
- Liaise with relevant personnel to ensure appropriate, timely input is provided for post market reports.
- Review field action information to determine if reportable in local country.
- Liaise with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.
- Advanced degree in scientific, technology or legal disciplines.
- Experience in a medical device or pharmaceutical industry.
- Knowledge of Quality Management Systems (QMS).
- Experience working across cultures/countries/sites.
- Demonstrated experience interfacing with regulatory agencies including PPB; TFDA, MHLW, Health Canada, etc. and standards bodies such as KEBS, TBS, AAMI, IEC, ISO, UL.
- PPB credentials for accessing PPB online portal.
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
- Demonstrated understanding of healthcare environment and knowledge of current competitive commercial or political situations and their impact on the Organization Healthcare regulatory strategies.
How to Apply
If you are qualified and up to the challenge send your Resume and Cover Letter to email@example.com by 7th March 2019. Please note that only qualified candidates will be contacted.