Are you a regulatory compliance expert with a passion for ensuring medical devices meet global standards? Join our leading Medical Firm based in Houston, TX, as a Medical Device Regulatory Compliance Strategy Manager and play a pivotal role in shaping the firm’s compliance strategy to ensure the safety, efficacy, and regulatory adherence of its innovative medical devices.
About Our Client:
Our client is a renowned leader in the medical device industry, dedicated to advancing healthcare through innovative technology and rigorous safety standards. With a commitment to delivering safe and effective medical devices to market, they are shaping the future of patient care. As they continue to expand, they seek a strategic leader to drive their regulatory compliance initiatives and ensure their devices meet stringent global regulatory requirements.
Responsibilities of the Medical Device Regulatory Compliance Strategy Manager:
As the Medical Device Regulatory Compliance Strategy Manager, you will be responsible for:
- Regulatory Strategy: Developing and implementing regulatory compliance strategies to ensure alignment with FDA, EU MDR, and other global regulations.
- Compliance Management: Overseeing the entire compliance lifecycle, from product development to post-market surveillance, ensuring adherence to regulatory standards.
- Risk Assessment: Conducting regulatory risk assessments and implementing mitigation strategies to minimize compliance risks throughout the product lifecycle.
- Cross-functional Collaboration: Collaborating with R&D, quality, and manufacturing teams to ensure regulatory compliance is integrated into every stage of product development and production.
- Regulatory Filings: Leading the preparation and submission of regulatory documents, including 510(k) submissions, PMAs, and technical files.
- Training and Education: Ensuring continuous education and training for teams on regulatory requirements and compliance best practices.
Qualifications:
To excel in the role of Medical Device Regulatory Compliance Strategy Manager, you should possess:
- Extensive Experience: Proven experience in regulatory compliance roles within the medical device or healthcare industry.
- Regulatory Knowledge: Deep understanding of global regulatory frameworks such as FDA regulations, ISO standards, and EU MDR.
- Strong Leadership: Excellent leadership and project management skills, with the ability to lead cross-functional teams and navigate complex regulatory landscapes.
- Problem-Solving: Ability to anticipate regulatory challenges and develop strategic solutions to maintain compliance.
- Educational Background: A bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or a related field; RAC certification or equivalent is highly desirable.
How to Apply:
If you’re a regulatory compliance professional ready to drive strategy and ensure the safety and efficacy of cutting-edge medical devices, we encourage you to submit your resume and cover letter detailing your qualifications and vision for the role. Take the lead in ensuring regulatory excellence and join our team in delivering innovative healthcare solutions.
Looking for more regulatory leadership roles? Explore opportunities with our Expert Medical Device Executive Recruitment team today!
