Regulatory Affairs Specialist
13 hours ago
Avanos is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements in the assigned markets throughout the product lifecycle.
Key Responsibilities:- Assist in providing regulatory input and technical guidance to the global RA team on product regulatory requirements in the assigned markets.
- Coordinate and support the development of optimum regulatory submission strategy for assigned projects in collaboration with the global team and regional commercial partners.
- Manage the preparation and submission of regulatory submission packages to health authorities.
- Assist in identifying and communicating issues early in the submission preparation stage that could impact product launch.
- Work closely with the global RAQA team to provide appropriate responses to health authorities' queries during the evaluation process.
- Close follow-up with health authorities during the evaluation process to ensure timely regulatory approvals.
- Diploma or Bachelor's degree in life sciences or engineering background.
- Regulatory and quality background preferably in medical devices or life sciences technology-driven company with at least 2 years of relevant experience.
- IT-savvy and highly proficient in Microsoft Excel, Word, and PowerPoint.
- Good command of spoken and written English.
- Team player.
- Ability to work independently with minimum supervision.
- Knowledge of US FDA and EU medical device regulations.
- Familiarity with IVD, drug-device/device drug, cosmetics, or OTC products.
- Good business acumen and interpersonal skills.
- Execution excellence.
- Entrepreneurial and innovative.
- Results-oriented and driven individual.
- Adaptable and agile.
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