Senior Analyst Regulatory Affairs

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 Senior Regulatory Affairs Analyst is responsible for ensuring the understanding and translation of regulatory and product compliance requirements, regulatory tasks execution and driving organizational alignment with current and new regulatory requirements by executing plans and through coordination across cross-functional teams. Provide hands-on support to Quality and Regulatory Affairs continuous improvement projects and process development and participate as a member of the organization quality and regulatory team.

Main Activities/Responsibilities:

• Overall responsibility for regulatory and compliance for respiratory and mobility aid products, working with a team in a matrix organization structure
• Review and interpret active regulations and upcoming changes, implement actions to meet changing requirements.
• Maintain up-to-date understanding and anticipate changes to global standards and regulatory requirements that may impact the Drive DeVilbiss Healthcare product portfolio.
• Ensure compliance with all regulations for EU and US as applicable (e.g. RoHS, Reach, PFAS and Prop 65), for all products.
• Collaborating with cross-functional teams including engineering, manufacturing, regulatory, quality, clinical affairs, and others.
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand critical milestones, proactively identify and mitigate risks, and identify meaningful opportunities for acceleration. Drive escalation and represent submission team at governance meetings.
• Responsible for state related pharmacy and bedding license process.
• Other duties as assigned by management.

Competencies:

• Experience with regulatory submissions (e.g. FDA, Health Canada, EU commission).
• Application of FDA, EU and other regulatory agency regulations, guidance, policies, and procedures pertinent to medical devices, including, but not limited to, ISO 13485,ISO 14971, UDI/GUDID.
• Knowledge and experience of global medical device regulations including submissions for emerging markets, CE marking, and Canadian MDR plus EUMDR, UKCA, EUDAMED, and other international Regulations.
• Knowledge and experience with Domestic and International Labeling Regulations, including but not limited to, Law and Flammability Labels.
• Knowledge of applicable ISO/IEC/ANSI/RESNA/UL/CSA standards and other performance standards.
• Ability to build team relationships and interface in a multi-disciplinary environment.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, including those with ambiguity and/or rapid change.
• Excellent skills in written, verbal communication, strategic thinking, and ability to interact with all levels of the organization and suppliers (domestic and foreign).
• Detail orientated with expertise in reading and interpreting regulations, directives, and standards.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
• Problem solving skills with ability to use and train on different problem-solving tools.

Reporting Relationships and Supervision:

• Reports to the Senior Director, Regulatory
• No supervisory responsibility

Education and Experience:

• 7+ years’ experience in Quality and/or Regulatory in a Medical Device or similar regulated industry
• Bachelor’s degree in Regulatory Science, Life sciences, Engineering, or another relevant field
• Experience in using Medical Device Quality Management Systems is a plus
• Hands-on experience in FDA submissions, Canadian Medical Device Licensing, and Registration in emerging markets.

Why Apply to Drive DeVilbiss…

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

Pursuant to New York law, Drive DeVilbiss Healthcare provides a salary range in job advertisements. The salary range for this role is from $68,960.00 to $80,000.00 per year. Actual salaries may vary depending on factors such as the applicant’s experience, specialization, education, as well as the company’s requirements. The provided salary range does not include bonuses, incentives, differential pay, or other forms of compensation or benefits which may be offered to the applicant, if eligible according to the company’s 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.