Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Manager, Regulatory Affairs at Rinnai America managing governmental affairs and regulatory compliance for water heating products. Working cross-departmentally to ensure adherence to regulations and support product development.
Responsibilities
- Providing an experienced regulatory individual to Rinnai America for helping achieve corporate mission statement of “Quality is our Destiny”
- Tracking, managing, coordinating the affairs of the Regulatory Governmental Affairs Committee
- Gathering and prioritizing regulatory and related government issues
- Assisting in defining the appropriate response and strategy
- Working closely with innovation, legal, sales, marketing and other company departments
- Ensuring initiatives support company’s overall strategy and goals
- Maintaining a deep understanding of new and existing regulations that may impact organization’s products & processes
- Using that understanding to assist in standardizing all business operations and establish clear, documented protocols
- Explaining regulations, procedures, and policies to all employees and stakeholders
- Participating in associational memberships and governmental interactions
- Reviewing marketing, legal, and technical documentation to assess compliance
- Recommending courses of remediation to help company achieve necessary levels of compliance
- Monitoring, aggregating, and maintaining issue, regulatory, and legislative logs for Regulatory Government Affairs Committee
- Reporting on compliance status and measures to both internal and external parties
- Coordinating activities of company leadership and Regulatory Government Affairs Committee
- Acting as a liaison between Company and state, local, federal, and international agencies
- Establishing and maintaining strong relationships with relevant government agencies, industry associations, and policy makers.
- Monitoring legislative and regulatory developments that may impact the hot water heater industry
- Representing the company in industry forums and participating in advocacy efforts to shape favorable policies
- Developing and implementing advocacy strategies to positively influence regulatory and legislative outcomes
- Collaborating with internal teams to communicate the company’s positions on key policy issues
- Providing guidance to internal teams on regulatory requirements affecting product design and development.
Requirements
- Bachelor of Science in Mechanical Engineering or similar discipline
- Minimum 4 years of experiences experience in an engineering/regulatory compliance discipline and product development expertise related to Rinnai’s current and future product portfolio.
- Must understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, to ensure the decisions work well throughout the lifecycle of the products and to set appropriate precedent for future products and projects.
- Experience with AHRI and similar industry associations.
- Experience with mechanical systems or water heating product design and application a plus
- Experience with SolidWorks or similar 3D software.
- Experience developing products via New Product Development process (Stage Gate)
- Open issues tracking to resolution.
Benefits
- Best-in-class health benefit programs that provide eligibility on 1st day of employment
- 401k match
- Paid Volunteer Community Service Day
Job title
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Experience level
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