PharmEng Technology is currently seeking a MDR Trainer
to assist our team for projects in Boston, Massachusetts. The position is available immediately conditional of a successful interview.
- Direct and manage project development from beginning to end.
- Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
- Develop full-scale project plans and associated communications documents.
- Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
- Liaise with project stakeholders on an ongoing basis. Estimate the resources and participants needed to achieve project goals. Draft and submit budge proposals, and recommend subsequent budget changes where necessary. Where required, negotiate with other department managers for the acquisition of required personnel from within the company.
- Determine and asses need for additional staff and/or consultants and make the appropriate recruitments if necessary during project cycle. Set and continually mange project expectations with team members and other stakeholders.
- Gathering, evaluating, organizing, managing and collating information in a variety of formats.
- Maintain familiarity with company product ranges.
- Plan, undertake and oversee product trials and regulatory inspections.
- Keep up to date with changes in regulatory legislation and guidelines.
- Offer advice about company policies, practices and systems
- Obtain marketing permission.
- Outline requirements for labelling, storage and packaging.
- Use a variety of specialist computer applications.
- Liaise and negotiate with regulatory authorities.
- Provide advice about regulations to manufacturers/scientists.
- Write comprehensible, user-friendly, clear, product information leaflets and labels.
- Ensure that quality standards are met and submissions meet strict deadlines.
- Prepare documentation.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
- Bachelor’s degree in a science / engineering field.
- Senior Expert in Canadian Medical Devise Regulations for Training.
- Over 10 years in industry specialized in Canadian Medical Device Regulations.
- Demonstrated experience in personnel management.
- Experience at working both independently and in a team oriented, collaborative environment is essential.
- Can conform to shifting priorities, demand and timelines through analytical and problem-solving capabilities.
- Reacts to project adjustments and alterations promptly and efficiently.
- Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines.
- Persuasive, encouraging, and motivating.
- Ability to elicit cooperation from a wide variety of sources, including upper management, clients and other department.
- Ability to defuse tension among project team, should it arise.
- Ability to bring project to successful completion through political sensitivity.
- Strong written and oral communication skill.
- Strong interpersonal skills.
- Adept at conducting research into project related issues and products.
- Ability to effectively prioritize and execute tasks in a high pressure environment is crucial.