Lead Regulatory Specialist- Medical Device

The Opportunity:

Avantor is looking for a strategic and results-driven Lead/ Regulatory Specialist for the Regulatory Affairs/ Product Compliance organization. The successful candidate will support both the Medical Device and Biopharma sectors.

This role is full-time, USA (northeast preferred) - Remote.

Minimum Education:

• Bachelor’s Degree (Biology, Pharmacy, Chemistry, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or related).

Required Experience (2+ yrs):

• In a regulated industry (IE: pharmaceutical, medical device).
• With ICH Q7, IPEC, and/ or 21 CFR 820.

Preferred Experience:

• With US Drug Master File, Canadian Master File, China Registration, and other international regions.
• Working with state regulations for regulatory block release.
• Business level leadership skills.
• Being responsible for the development & maintenance of related SOPs and best practices.
• Project Management experience.
• With GMP manufacturing, compendial compliance, validations, impurities analysis, stability, and/or general auditing experience.

How you will thrive and create an impact:

Avantor has a robust Regulatory Affairs department focused on ensuring compliance with national and international laws and regulations. Bringing business level verbal, written communication and interpersonal skills, the Lead Regulatory Specialist will communicate with customers, suppliers and fellow associates. 

This role will equally support:

• Prescription Medical Device Regulatory Operations
• Biopharma Dossier and Customer Support

Prescription Medical Device Regulatory Operations

• Lead a team in completing regulatory documentation review and release of prescription Medical Device product regulatory holds.
• Define and maintain regulatory strategy with legal and regulatory leadership.
• Support internal and external customer meetings to explain our regulatory operations strategy and requirements for compliance.
• Collaborate cross departmentally to support product classification of Prescription Medical Devices.
• Apply for and maintain Device facility registrations and listings with the USFDA under CDRH.
• Ability to research regulations and conduct new product evaluations for Medical Device and Cell and Gene Therapy product setups.
• Knowledge of state and federal Prescription Medical Device and Cell and Gene Therapy regulations.
• Collaborate with Quality in the creation of Quality Agreements.
• Conduct training for Medical Device team and commercial. 

Biopharma Dossier and Customer Support

• Support Biopharma team in the compilation, maintenance, and submission of drug substance regulatory dossiers including Drug Master Files and product registrations globally.
• Develop/ train teams, create project plans, and establish timelines for growth opportunity projects and maintenance activities.
• Collaborate cross- departmentally to prepare additional information or responses requested by regulatory agencies.
• Prepare responses to customer requests, such as product data, Master File status, written regulatory affairs statements, and/or questionnaires.
• Evaluate complex issues, create recommendations, evaluate risk, and provide reporting to summarize processes.

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 t