Regulatory Affairs Specialist, Sea

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics.

Join our talented team at a global medical device company focused on helping surgeons treat their patients better.

Main Objective :

Responsible for the daily operations of regulatory affairs and ensures regulatory submissions meet local and regional compliance requirements.

Staying abreast with regulatory compliance requirements and changes affecting company operations and products.

Generates and manages submission documents for new products or changes to existing regulatory submissions.

Essential Duties and Responsibilities :

Regulatory Affairs (RA) Submissions and Applications

Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)

Communicating with regulators on submission projects

Prioritising and organising multiple projects with competing priorities

Participating in regulatory affairs planning for SEA markets

Providing support in APAC level projects as and when needed

Reviewing product labelling and Directions for Use (DFU), if any translation is required

RA Compliance and Document Control

Maintaining critical regulatory information such as product license, submission dossier, change information on the Regulatory Information Management System (RIMS) and other applicable databases

Evaluate and address changes to existing products to ensure compliance with local regulatory requirements

Assess and communicate impact of product change information to relevant stakeholders

Ongoing Education and Training

Proactively attending seminars, lectures and academic conferences to continuously develop skills and to collect and share insights

Regulatory Intelligence

Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes

Providing input to change management projects for global regulatory change assessments

Participating and providing support in cross-functional collaboration on new product and country launches

Product Recall and Complaint Support

Supporting product safety alert activities and field actions

Assisting in activities relating to post-market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and / or liaising with regulatory bodies in assigned countries)

Participating in both internal and external quality system audits

Incidental Duties :

The above statements describe the general nature and level of work being performed in this job.

They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience :

Degree qualified preferably in an Engineering or Science discipline

Minimum 2–3 years direct RA experience within a medical device company

Knowledge and Skill Requirements / Specialised Courses and / or Training :

Strong working knowledge of SEA medical device regulations and standards

Knowledge of global regulations will be advantageous

Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels

Ability to work both independently and as part of a team to effectively contribute in both individual and collaborative settings

Ability to manage multiple tasks and prioritise work in a dynamic, fast-paced environment

Comprehension of technical, engineering or medical terminology, and / or ability to reference literature for understanding

Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

Machine, Tools, and / or Equipment Skills :

PC, database, research tools, internet research tools

MS Office skills (Word, Excel, PowerPoint, Outlook)

Reasoning Ability :

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills :

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills :

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.

Ability to verbally communicate ideas and issues effectively to other team members and management.

Ability to write and record data and information as required.

Physical Demands :

Good physical and mental health.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear.

The employee is frequently required to be mobile and must be able to lift and / or move up to 5 kilos.

Vision Requirements :

Meets vision requirements to use personal computer and read documents.

Work Environment :

Regularly work at the Buona Vista office or visit to vendor / supplier locations.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Internal and External Relations :

The position maintains ongoing relationships with internal stakeholders, Arthrex customers, and regional / global teams in order to support / perform duties in this position.

It is required the ability to obtain cooperation and convey accurate information in a timely manner.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Title : Regulatory Affairs Specialist, SEA

Location : Singapore, 03, SG,

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