Regulatory Affairs Specialist

Date: 02-Aug-2022

Location: Singapore, 01, SG

Company: Teleflex

JOB PURPOSE:

Creates and executes regulatory strategies for Asia/Pacific registrations and participates in any resultant compliance activities.

 

KEY RESPONSIBILITIES:

Key responsibilities will include (but are not limited to) the following:

  • Participate and coordinate in the development of regulatory strategies, in conjunction with the needs of the company, for each product range and change. Establish regular review with Sales & Marketing and other relevant stakeholders to ensure the strategies are in alignment with company needs and marketing strategy. Identify risks and/or changes to the strategies (if any) and involve the relevant stakeholders for discussion on action plan.
  • Liaise with the necessary parties, country RA, registration agents, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for designated market.
  • Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses. Review the technical documents obtained from different source before submission to external party and/or authority to ensure the documents meet and/or fulfill the country requirement/request. Ensure the documents are legalized and/or notarized where required.
  • Monitor and update registration activities and/or status to all relevant stakeholders in regular basis. Ensure the required actions and responses are in place in a timely manner. Identify and report any delay to the registration timeline and involve the relevant stakeholders for discussion on action plan.
  • Ensure timely approval of registration in targeted markets. Identify risks and propose options/solutions to relevant stakeholders and management.
  • Manage changes to licenses due to product/manufacturing related changes to minimize or prevent risk/impact to business. Ensure proper processes are in-place to ensure effective management of changes with consideration of inventories cut in in accordance with license approval.
  • Monitor license expiry and establish routine follow up with the affected countries to ensure license renewal to be conducted in a timely manners.
  • Participates and supports team in business interactions and negotiations with regulatory agencies on submission requirements, labeling claims, etc. 
  • Ensure on time reporting of adverse events to authority. Reviews complaints for potential adverse events and that reports of adverse events are submitted to appropriate agencies in accordance with established procedure and domestic and international regulations and standards.
  • Maintain quality system/GDP procedures  and support on-site audits for Malaysia establishment

 

KEY RELATIONSHIPS / INTERFACES

  • Senior Regulatory Affairs Manager
  • QARA group, International
  • QARA group, US
  • External notified bodies and authorities

 

ESSENTIAL SKILLS / EXPERIENCE

  • Min. Diploma/Bachelor's degree in Science Discipline
  • Min 2-3 years regulatory experience working in a medical company doing business within SEA
  • Individuals who have obtained a Regulatory Certification are a plus.
  • Previous experience working for a medical device manufacturer
  • Detail oriented, with emphasis on accuracy and completeness
  • Effective written and oral communication skills
  • Good organizational and planning skills; drives for results
  • Effective analytical/problem solving skills
  • Good interpersonal skills that include working well in a team environment and the ability to lead others.
  • Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
  • Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision.
  • Ability to identify areas of concern in moderately complex projects and manage change
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint)

 

BEHAVIOUS / VALUES

  • Possess good  organizational and analytical skills
  • Team player with hands on experience in related field
  • Pragmatic and able to think and operate inter-departmentally and not lose sight of priorities in the hectic day-to-day operations
  • Possess a high level of communicative skills, the ability to persuade and self-assertion
  • Ability to work under pressure analytically and systematically
  • Quick comprehension, thinking in terms of the big picture and organizational skills
  • Ability to integrate and get along with people of differing backgrounds and agendas
  • Ability to quickly establish credibility at all levels in the organization

 

Expected Travel: None

Requisition ID: 6528

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.