50 applicants

Company

ANEUVO · 1 day ago

Regulatory Affairs Manager

United States

Full-time

Remote

Senior Level

7+ years exp

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Responsibilities

Develop and implement regulatory strategies to ensure timely product approvals and compliance with local and international regulations.

Stay updated on regulatory trends and changes, providing strategic insights to internal teams.

Prepare, review, and submit high-quality regulatory filings, including INDs, PMAs, 510(k)s, and international submissions (CE Mark, MDR, etc.).

Maintain and update regulatory listings, licenses, and databases.

Partner with Quality Assurance, R&D, and Marketing teams to ensure compliance throughout product development, launch, and commercialization.

Review and approve product labeling, advertising, and promotional materials for regulatory compliance.

Lead communications with regulatory bodies (e.g., FDA, notified bodies) and manage regulatory inspections and audits.

Ensure compliance with internal policies and external regulations, including participation in internal and external audits.

Oversee the creation and maintenance of regulatory documentation, including product labels and technical files, in multiple languages.

Manage product logistics and regulatory requirements for seamless delivery to global markets.

Mentor and guide junior regulatory affairs team members, fostering a culture of compliance and continuous improvement.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsMedical Device ExperienceUS FDA CDRHEU MDR 2017/745Regulatory SubmissionsUK MHRAQuality Assurance/Quality ControlRegulatory Affairs Certification (RAC)

Required

Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.

7+ years of experience in regulatory affairs, preferably in the medical device, pharmaceutical, or biotech industry.

Working knowledge and experience with US and OUS (Outside the US) medical device regulatory requirements and entities.

Strong knowledge of FDA regulations, EU MDR, and other global regulatory frameworks.

Proven experience in preparing and managing regulatory submissions.

Excellent organizational skills and strong attention to detail.

Strong written and oral communication skills, with effective problem-solving abilities.

Ability to work independently with minimal supervision while managing multiple tasks in a fast-paced environment.

Professional demeanor in handling challenges and resolving issues.

Quick, adaptable learner with a resourceful approach to achieving goals.

Preferred

Experience with Quality Assurance/Quality Control (QA/QC) processes is a plus.

Regulatory Affairs Certification (RAC) is a plus.

Benefits

Medical, dental and vision insurance

Employee stock option

Company

ANEUVO

ANEUVO® is a Platform and Therapy Development company focused on treating chronic injuries and conditions that have not been curable through traditional pharmaceutical approaches.

Founded in 2016

Los Angeles, California, USA

11-50 employees