Regulatory Affairs Specialist

Local Jobs Sealed Air Corporation
  • New Zealand, Hamilton, Waikato View on Map
  • Post Date: June 24, 2020
  • Apply Before : July 24, 2020
  • Share:

Job Description

Regulatory Affairs Specialist

Date: Jun 13, 2020
Location:
Hamilton, WKO, NZ
Sealed Air partners with customers to solve their most critical packaging challenges with innovative solutions that leave our world, environment, and communities better than we found them. Our portfolio of widely recognized brands includes Cryovac® food packaging and Bubble Wrap® protective packaging which respectively enable a safer, more efficient food supply chain and protect valuable goods shipped around the world. Sealed Air generated $4.7 billion in sales in 2018 and has approximately 15,500 employees who serve customers in 123 countries. To learn more, visit www.sealedair.com.
Summary
Reporting to the Principal Regulatory Affairs Specialist the Regulatory Affairs Specialist manages the regulatory affairs issues within the ANZ Commercial organizations, coordinates and ensures the implementation of compliance activities for all commercial products and gives direction to R&D and Regulatory Affairs organization on relevant matters.
In this position you will:
  • Lead and coordinate the regulatory affairs activities in ANZ relevant to commercial products by working in the Division’s Regulatory Team.
  • Ensure that future regulatory trends and changes in Countries are identified, understood, and communicated promptly to Leadership so that future business strategies can be formulated to allow business continuity and competitive advantages when applicable.
  • Ensure that company policies and procedures in the regulatory affairs area are understood and implemented in ANZ.
  • Engage with external groups and governmental authorities to understand the country regulatory requirements, the deviations from other international legislation such as EU and FDA, and determine relevance to Sealed Air products in ANZ and foresee (potential) future regulatory developments.
  • Ensure that the position is appropriately resourced and equipped to carry out the required range of activities, ensuring product compliance and providing customer/business with support in the identified areas of focus.
  • Meet agreed performance targets, including customer satisfaction requirements, continuous learning requirements, operational knowledge requirements, and adopting best practices to ensure optimal efficiency.
  • Plan and develop personal expertise through training in the identified areas of focus.
  • Contribute to develop and ensure compliance to agreed regulatory affairs processes.
  • Maintain a safe and incident-free working environment.

Responsibilities
  • The Regulatory Affairs Specialist will provide services necessary for ongoing regulatory affairs support to the ANZ organization and current/prospective customers to maintain and grow the business.
  • Accountable for ensuring we provide best-in-class service to both internal and external customers/stakeholders.
  • Accountable for ensuring the position is adequately resourced and equipped for the tasks it requires to implement, adequately trained and updated on new/existing regulatory requirements, and prepared for the future needs of the business resulting from regulatory trends and changes.
  • Accountable for understanding the Regulatory Affairs’ Strategy, and Sealed Air’s overall strategy.
  • Stays updated on regulatory trends and changes relevant to Sealed Air.
  • Responsible for collaborating with the rest of the R&D team to ensure sharing of best practices and consistency in communication across the Regulatory organization.
  • Responsible for oversight and communication with regulatory authorities and other external parties in accordance with applicable guidelines and regulations in the markets served by Sealed Air.
  • Accountable for driving safe working practices.
Qualifications
  • Depth of experience and understanding of the specialty materials, plastics, or chemical industries, including knowledge of customers.
  • Excellent interpersonal skills to influence business strategy and decisions
  • Comfortable with change and able to serve as a change agent to assist the organization in embracing new ideas and drive growth.
  • In-depth knowledge of regulations in key markets of operation.
  • Business acumen to collaborate effectively across functions, regions, and the business unit to drive results and ensure goals are achieved.
  • English mother tongue; Chinese bilingual preferred
  • Effectively communicates verbally and in writing to influence decision-making and ensure the organization understands the impact of the issues.
  • Technical degree, preferably in chemistry.
  • Definite advantage in interacting with remote or dispersed teams.
  • Demonstrates desire for continuous development.
  • Must work in a major ANZ location (preferably Hamilton, New Zealand).


Requisition id:
29496
Relocation: Yes
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability or protected veteran status. Sealed Air participates in the E-Verify Program (US sites only).
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Regulatory Affairs Specialist

Local Jobs Baxter International
  • United States, Saint Paul, MN 55114 View on Map
  • Post Date: June 9, 2020
  • Apply Before : July 9, 2020
  • Share:

Job Description

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.


Summary

Regulatory Affairs Specialist is responsible for the development and implementation of global regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Additionally, providing on-market regulatory support for currently registered global products and expansion of products into new markets.


Duties and Responsibilities

  • Global Regulatory Lead for a portfolio of Class II / Class I medical devices marketed worldwide.
  • Represent global regulatory affairs and act as a liaison for local country RA on cross-functional project teams
  • Ensure regulatory activities are in alignment with business prioritization
  • Track of status and progress of regulatory documentation and deliverables required to support regulatory submissions
  • Manage product lifecycle activities including regulatory impact assessments of product changes and product labeling development
  • Maintain regulatory files in a format consistent with regulatory requirements and internal procedures
  • Support local country RA on product Geographic expansion initiatives and product lifecycle activities
  • Provide guidance and regulatory strategies to project teams supporting new product development
  • Respond to regulatory authority inquires under strict deadlines
  • Assist with maintenance activities for regulatory systems and procedures
  • May act as primary contact with US FDA and/or EU agencies for standard activities related to product development or compliance


Qualifications

  • Required Bachelor’s degree or country equivalent in a scientific discipline with a minimum of 5 years regulatory or equivalent experience within a healthcare company, contract manufacturer, or similar organization. Ideal candidate will also possess working knowledge of medical device registration regulations in the United States. EU and international experience / knowledge in medical device regulations will be an advantage
  • Scientific knowledge and ability to discuss technical matters with cross-functional teams.
  • Good written and verbal communication and presentation skills
  • Good technical system skills (e.g. word processing, spreadsheets, databases, online research, Document Management System)
  • Manage multiple projects, activities, priorities and deadlines
  • Ability to identify compliance and / or project risks and escalate when necessary


Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law – Poster Supplement
Pay Transparency Policy


Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

 

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Remote: Office Not Required

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For too long our lives have been dominated by the ‘under one roof’ Industrial Revolution model of work. That era is now over. There is no longer a reason for the daily roll call, of the need to be seen with your butt on your seat in the office. The technology to work remotely and to avoid the daily grind of commuting and meetings has finally come of age, and bestselling authors Jason Fried and David Heinemeier Hansson are the masters of making it work at tech company 37signals. Remote working is the future – and it is rushing towards us.

VIEW BOOK


Why Working-From-Anywhere-Companies Attract the Best Talent: A Guide for Companies, Employees and Remote Job Seekers

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If your dream job is not related to a location, an office or a cubicle farm, then this book is for you. Look at a job in a totally new way and start enjoying life while being more productive.

Employers will like this book and embrace working-from-anywhere to have more engaged employees, attract top talent and save big on the bottom line.

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