Senior Manager, Regulatory Affairs Product Management

Date: 6 Jun 2024

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 10144

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep understanding of global regulatory requirements, a strong track record in navigating complex regulatory landscapes, and the ability to collaborate across cross-functional teams. The Senior Manager of Regulatory Affairs for Teleflex will lead regulatory strategies, submissions, and compliance initiatives, contributing directly to the company's growth and reputation within the medical device industry.

Principal Responsibilities

  • Oversee the development and execution regulatory strategies for new product development, including classification, pathway selection (510(k), PMA, De Novo, etc.), and global market access.
  • Provide leadership for the team including performance management, Key Talent Development, succession planning, and employee development. 
  • Partner with R&D, Clinical, Quality and Design Assurance, Legal, and Marketing teams to ensure alignment on regulatory strategy, submissions, product lifecycle planning and compliance activities.
  • Oversee the preparation, review, and submission of regulatory documents to regulatory authorities, domestic and other international agencies, ensuring compliance with relevant regulations and guidelines.
  • Manage negotiation and maintain interaction with regulatory authorities worldwide during the development and review/queries process to ensure submission approval and clearances.
  • Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes. Implement risk mitigation strategies as needed.
  • Ensure preparedness and support of regulatory agency audits, inspections, and interactions, including facilitating document requests, coordinating responses, and addressing findings.
  • Monitor impact of changing evolving global regulations on submissions, guidance documents, best practices procedures and communicate to internal stakeholders.
  • Provide regulatory due diligence and integration strategies for mergers, acquisitions, and partnerships to ensure smooth transitions and compliance, as needed.
  • Maintain organized and up-to-date regulatory files, records, and documentation, ensuring accessibility and accuracy for internal and external stakeholders.
  • Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

  • Bachelor’s degree in science, engineering, or related field of study. Equivalent experience may be acceptable in lieu of a degree.
  • 7 to 10 years of related Medical Device Regulatory Affairs with experience in Class I and II devices, Class III experience is preferred.
  • 5-7 years leadership experience including the proven ability to lead and motivate others.
  • RAC certification is a plus.

Specialized Skills / Other Requirements

  • Experience with demonstrated leadership skills.
  • Ability to apply business and Regulatory Affairs ethical standards
  • Excellent analytical and critical thinking skills to develop creative solutions and meet objectives
  • Strong verbal, written, and presentation skills
  • Ability to partner with and influence others without direct authority, build consensus and look for collaboration with people from different departments and all levels, and manage multiple priorities and meet deadlines
  • Proficient in MS Word, Excel, Power Point, and Outlook required
  • Able to travel domestically and internationally.

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.