Our client is seeking a Regulatory Affairs Manager to oversee regulatory activities and ensure product compliance across global markets. This individual will play a key role in guiding regulatory strategy, managing submissions, and supporting the introduction of new products into the market. The ideal candidate brings strong leadership, deep regulatory expertise in the medical aesthetics industry, and the ability to collaborate across cross-functional teams in a dynamic, fast-paced environment.
Responsibilities
- Develop, implement, and maintain regulatory strategies to support product development and market expansion initiatives.
- Prepare and manage regulatory submissions, including 510(k)s, international dossiers, and post-market filings.
- Serve as a liaison with regulatory agencies to ensure timely approvals and resolve any compliance issues.
- Monitor and interpret regulatory requirements, ensuring internal practices remain compliant.
- Support new product development efforts by contributing regulatory input during all phases of the design and development process.
- Lead or contribute to the creation and improvement of regulatory SOPs and plan templates.
- Review and provide input on Clinical Synopses and other documents supporting product claims.
- Collaborate cross-functionally with R&D, Quality, Clinical, and Marketing teams to ensure alignment on regulatory pathways and timelines.
- Maintain up-to-date knowledge of APAC and other international regulatory requirements.
- Support internal audits, inspections, and continuous improvement initiatives.
- Participate in Agile project teams, offering regulatory guidance as needed.
Qualifications
- Bachelor’s or Master’s degree in a scientific, engineering, or related discipline.
- Proven Regulatory Affairs experience in the medical aesthetics or medical device industry.
- In-depth understanding of global regulatory requirements and processes, particularly for U.S. and APAC regions.
- Demonstrated experience with new product development and regulatory strategies for product introduction.
- Strong knowledge of regulatory documentation and planning tools, including regulatory plan templates.
- Experience with Clinical Synopsis documentation is a plus.
- Agile experience is a plus.
- Exceptional analytical, problem-solving, and communication skills.
- Highly organized and detail-oriented, with the ability to manage multiple priorities and deadlines.
Location
Employment Type
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled