Senior Regulatory Specialist

The Opportunity:

Avantor is looking for a Senior Regulatory Specialist to join our organization, supporting our Avantor Fluid Handling business. They will execute product compliance strategies, policies and processes to ensure that the company’s products meet regulatory standards and compliance certifications are obtained and maintained. Participate in product design reviews, identifies and interprets applicable regulatory standards and requirements; provide guidance and training to prevent compliance issues from the initial product design throughout production and delivery of the final product.

This role will be a full-time, remote position. 

What we’re looking for  

• Education: Bachelor’s degree in Science, Engineering or related work experience

• Experience: 5+ years experience in some combination of Quality and Regulatory roles, some portion of which must include an environment related to medical devices and/or biopharmaceuticals.

• Knowledgeable of the cGMPs (21CFR Parts 820, 210, 211) and USP/ISO Standards related to process validation, biocompatibility and sterility.

• Strong experience with MS Office.

• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required.

• Ability to interact effectively with all levels of the organization and perform multiple tasks in a somewhat fast-paced environment.

• Effectively communicates, in writing and verbally, at all levels both internally and externally.

How you will thrive and create an impact  

• Collaborates with multi-site engineering, manufacturing and sales functions and interacts with customer organizations to generate and provide new customer part qualification packages.

• Maintains the customer part qualification and approval packages in each customer’s current part number files.

• Supports the ongoing Sterility Validation program in accordance with ANSI/AAMI/ISO 11137, including quarterly dose audits.

• Generates the Certificates of Quality; based on the defined criteria for all manufactured products.

• Maintains the files of supplier validation packages and compliance information; interacts with supplier Quality/Regulatory organizations to establish and maintain this data.

• Handles, completes and responds in a timely manner to customer questionnaires and surveys related to product compliance.

• Manages annual component bioburden testing. Maintains an ongoing list of part numbers to be tested, schedule the testing, prepare the samples in the cleanroom and send the samples to the approved laboratory for testing.

• Assists the cleanroom certification program including annual re-certification.

• Assists the ongoing cleanroom viable micro-organism monitoring program.

• Assists the maintenance of the Sterile Barrier Packaging Validation program in accordance with ANSI/AAMI/ISO 11607, along with the cleaning and compressed air validation programs.

• Supports department’s various validation and testing projects, as required.

• Assists in developing, revising and writing Standard Operating Procedures, as required.

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 contribut