The Opportunity:
Avantor is looking for Senior Associate for Regulatory Affairs Team. He should be experienced in medical devices to ensure on time compliance review and classification. Leading the development/maintenance of SOP, relevant regulatory documents, associated with US Federal and State regulation for prescription medical device while promoting best practice across the function. Facilitate in applying and maintaining facility licensing, registrations and devices licenses as required by US Federal and State regulations.
What we’re looking for
Education: Minimum of a graduate degree in a life science or an equivalent subject.
Preferred Qualifications:
Candidate with experience or knowledge in review/classification of medical device and instruments or regulatory/quality roles.
Knowledge in existing US Federal and State prescription device is preferred.
Excellent written and verbal communication skills
Strong knowledge in MS Office, MS Outlook; Excel proficiency is an advantage.
Strong attention to details
Decision making aptitudes based on given guidelines and in ambiguous context.
Very good knowledge and experience in internet navigation and research – finding specific information about products in a timely manner.
Flexible to US Shift
How you will thrive and create an impact:
Ensure on time review/oversee and release of prescription device orders as per agreed SOP and service level agreement
Prepares product listing, facility registration and facility identification for submission to the US FDA
Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
Liaise with regulatory and other department to understand the licensing/registration requirement to facilitate in applying and maintaining the same to ensure compliance.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents associated with United States Federal and State Regulations for Prescription Medical Devices
Spearhead the project- engage with key stakeholder and other functions, work on gathering their requirements, provide estimation and work on deciding the accurate timelines.
Identify issues and risks, bringing them to attention of management and Participate in the problem resolution.
Perform data gathering, root cause analysis and performance trending to develop appropriate process change control.
Develop training curriculum, plan, documents and periodic reviews, updates & approvals.
Develop monitoring systems to ensure any change in the regulation is communicated effectively to all the associate involved to ensure compliance.
Create operational strategies to optimize the process and improve efficiency through Avantor Business System and upskilling.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
3rd party non-solicitation policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
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