Regulatory Affairs associate

Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 80 countries around the world.   

“Leading the World with Innovative Healthcare Solutions that Enhance Lives”

Summary (Major Purpose of the Role):  

 The Regulatory Affairs associate is vital in ensuring the adherence of our regulatory standards. Working within a matrix organization structure, you'll collaborate with a team to achieve compliance. This role plays a crucial part in ensuring the regulatory compliance of our products and facilitating their efficient and responsible market entry.

Main Activities/Responsibilities:

• Owning the process for state-related pharmacy and bedding licenses, as well as international registrations.
• Managing FDA renewals and international registrations, ensuring timely compliance.
• Maintaining a comprehensive understanding of global standards and regulatory requirements that could affect our product portfolio at Drive DeVilbiss Healthcare.
• Collaborating with cross-functional teams, including engineering, manufacturing, regulatory, quality, clinical affairs, and others.
• Translating regulatory requirements and strategies into actionable plans with detailed milestones, enabling teams to understand critical steps, identify and mitigate risks, and uncover opportunities for acceleration. You'll also represent the submission team at governance meetings.
• Conducting risk analyses to identify potential compliance risks and develop strategies to address them effectively.
• Completing any additional duties assigned by management.

 Competencies:

• Excellent research abilities
• Strong analytical and problem-solving prowess
• Proficiency in multitasking, prioritization, attention to detail, and organizational finesse
• Advanced computer proficiency, particularly in Excel and word-processing software
• Outstanding time and project management expertise
• Effective decision-making capabilities
• Adherence to confidentiality protocols in handling information

 Education and Experience:

• Bachelor’s degree in Health Science, Business Administration/Management or related field
• 1 years’ experience preferred

 Why Apply to Drive DeVilbiss…

Competitive Benefits, Paid Time Off, 401(k) Savings Plan

In accordance with New York law, Drive DeVilbiss Healthcare provides a salary range in job advertisements. The hourly wage for this role ranges from $22.69 To 28.36 per hour. Actual wages may vary based on factors including the applicant’s experience, specialization, education, as well as the company’s requirements. Please note that the provided salary range excludes bonuses, incentives, differential pay, or other forms of compensation or benefits that may be available to eligible applicants in accordance with company policies. 

“Drive DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive DeVilbiss strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive DeVilbiss complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.”