RA Specialist APAC Indirect Markets
RA Specialist APAC Indirect Markets
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Job Description
Primary Function of Position
Essential Job Duties
- Execute the regulatory strategy for obtaining registration approval of Companys portfolio according to plan.
- With limited supervision coordinate with Distributor RA to compile regulatory documentation for submission to regulatory authorities maintenance of licenses and change management.
- Evaluate medical device changes determine and execute regulatory strategy and ensure compliance.
Roles and Responsibilities
- Work closely with respective BU RAs to execute regulatory plans for medical device registrations in APAC indirect markets.
- Communicate with Distributor RAs and Companys stakeholders (BU RAs Commercial PLO PMO Hardware Compliance etc. to ensure compliance with the relevant medical device regulations in APAC indirect markets including requirements for new product approval change management site registrations and license renewals etc. while supporting business objectives.
- Together with the Distributor RAs determine the types of regulatory submissions or internal documentation required during new product submissions change submission/variation/notifications etc.
- Input and manage regulatory submission tracking information maintained in Companys regulatory database/systems (Veeva PRDb Agile Smartsheet etc..
- Compile high quality submissions meeting technical requirements from regulatory authorities.
- Perform periodic regulatory surveillance activities (e.g. new/upcoming regulations) and necessary impact assessments (RSA) using TrackWise.
- Support other teams in ensuring regulatory compliance as required.
- Perform other tasks as assigned.
Qualifications :
Required Skills and Experience
- A bachelors degree in Medical Technology Life Sciences Pharma or similar sciences.
- 2 5 years of experience in medical devices registration in ASEAN countries. Fresh graduates (e.g. with relevant internship experience) are welcome to apply.
- Computer literacy (PC Microsoft Word/Excel/PowerPoint Outlook).
- Fluent in written and spoken English.
- Detailoriented.
- Organizational and planning skills including action orientation focused urgency and driving for results.
- Ability to multitask prioritize and schedule work to meet reporting or other deadlines.
- Good team player ability to collaborate and influence others.
- Excellent interpersonal skills.
- Knowledge of ISO13485 GDPMDS or similar quality management system requirements and broad understanding of what it takes to work in a regulated environment.
- Experience with Agile TrackWise or similar regulatory information management systems.
Additional Information :
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
