Avania is the only global CRO built for MedTech — integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle
Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.
Avania - MedTech's trusted Champion
Avania are hiring - Senior Regulatory Consultant
Compensation
The approved base salary is up to $150,000, depending on experience, plus a 10% bonus, plus Benefits. Avania may consider flexibility for a candidate whose expertise and experience closely match the needs of the role.
About the role
Avania is looking for a Senior Regulatory Consultant to strengthen our expertise in drug, biologic, and combination-product regulation. This role will support projects adjacent to our core medical device work, including biologic tissue products, drug-delivery devices, and other products that require clinical trials but do not fit neatly within a traditional medical device or pharmaceutical model.
You will serve as an individual contributor and work closely with internal regulatory experts to help Avania pursue and deliver this growing area of client work. The ideal candidate brings strong pharmaceutical or biologics regulatory experience and is interested in expanding their knowledge of the medical device landscape.
What you’ll do
- Provide regulatory expertise for US and EU drug, biologic, drug-delivery device, and combination-product projects.
- Support regulatory strategy and submissions for products that sit at the intersection of pharmaceuticals, biologics, and medical devices.
- Contribute knowledge of clinical trial submission processes for drugs and biologics.
- Work with internal subject-matter experts to translate complex regulatory requirements into practical guidance and project delivery.
- Partner with colleagues across Avania’s advisory and CRO functions to support existing projects and help build capability in adjacent life-sciences markets.
- Apply your pharmaceutical or biologics experience while developing deeper familiarity with medical device regulations and submissions.
Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role, and to use the criteria in this ad to declare which rank is commensurate with their experience.
What we’re looking for
- Prior regulatory experience within a pharmaceutical or biologics manufacturer, consultancy, or clinical research environment.
- Working knowledge of US drug and biologic regulatory pathways and submissions, including INDs, BLAs, NDAs, and eCTD.
- Experience interacting with or supporting submissions to FDA centers such as CDER or CBER.
- Knowledge of EU regulatory requirements and the EMA; experience with EU clinical trial submissions is beneficial.
- Experience with drug-delivery devices, combination products, or biologic tissue products.
- Familiarity with eCTD Module 3 and chemistry, manufacturing, and controls documentation.
- Understanding of relevant technical topics such as extractables and leachables, container-closure systems, or ISO 10993.
- Ability to communicate effectively with highly technical subject-matter experts and apply shared regulatory vocabulary to client work.
- Interest in learning and contributing to Avania’s core medical device regulatory work.
Candidates currently working at Manager or Associate Director level as individual contributors may be especially well aligned with the scope of this opportunity.
Applicants must be legally authorized to work in the United States or Canada at the time of hire. Candidates must have authorization to work in the United States or Canada that does not require current or future employer-sponsored visa sponsorship, as sponsorship is not available for this role.
Avania - MedTech's trusted Champion
Avania takes pride in being an equal opportunity employer. We consider 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.
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