Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)

The Opportunity

We are presently hiring for a Regulatory Affairs Specialist, as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA.

As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

What You’ll Work On

• Perform regulatory activities as below for APAC countries.
• Determine and communicate submission and approval requirements.
• Monitor applications under regulatory review.
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory submission strategies.
• Assist in the preparation and review of regulatory submissions to authorities.
• Assist compliance with product post-marketing approval requirements.
• Assist in the review of advertising and promotional items.
• Assist with label development and review for compliance before release.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Ensure product safety issues and product-associated events are reported to regulatory agencies.
• Individuals may provide limited work direction and guidance to peers and / or skilled non-exempt levels of employees.
• Participates in developing less experienced staff by setting an example, providing guidance, and offering counsel.
• Plans and organizes non-routine tasks w / approval. Initiates or maintains work schedule. Establishes priorities of given assignments.

May lead a departmental project team.

• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Participates in determining goals and objectives for projects.
• Influences middle management on technical or business solutions.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Required Qualifications

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development / support, scientific affairs, operations, or related area.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Master’s degree
• 1+ year of Regulatory Affairs experience within Medical Devices is strongly preferred.
• Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel;
• Principles and requirements of applicable product laws; Submission / registration types and requirements; GxPs (GCPs, GLPs, GMPs);
• Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations;

Ethical guidelines of the regulatory profession, clinical research and regulatory process.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
17 days ago