Regulatory Affairs Specialist Jobs

About The Position

Requirements

• Bachelor’s degree or equivalent.
• 2–3 years of experience in a regulated industry, such as medical products or nutritionals. Regulatory experience is preferred; experience in quality assurance, research and development/support, scientific affairs, operations, clinical, or a related area may also be considered. Higher education may compensate for years of experience.
• Ability to work in a team and complete projects in a fast-paced, matrixed environment.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Flexible schedule to attend meetings as needed with affiliates in other geographies.
• Strong problem-solving skills and the ability to think strategically and see the big picture.

Nice To Haves

• Bachelor’s degree in science (such as biology, chemistry, or microbiology), math, engineering, or a medical field.
• Master’s degree.
• Experience in the medical device industry.
• Experience working with NMPA (CFDA) or other international regulatory parties.
• Chinese/Mandarin language skills.
• Experience in a broader enterprise or cross-division business-unit model.
• Adaptability and ability to switch priorities while completing tasks.
• Process-oriented approach.
• Certification is a plus, such as RAC from the Regulatory Affairs Professionals Society.

Responsibilities

• Assist in preparing regulatory applications, with a focus on China, to meet departmental and organizational objectives.
• Review the applicability of medical device regulations and keep submission requirements current in regulatory submission databases and file systems; distribute information about new or modified requirements to appropriate personnel when requested.
• Determine and communicate submission and approval requirements and timelines to project teams.
• Evaluate proposed preclinical, clinical, design, and manufacturing changes for regulatory submission strategies.
• Track deliverables, follow up as needed, and help ensure project timelines are met.
• Provide regulatory impact assessments for changes to products that are already licensed.
• Represent Regulatory Affairs in reviewing and analyzing applicable regulatory guidelines.
• Work across functions to develop documents and required product information for regulatory submissions.
• Assist with label development and review labels for compliance before release.
• Support product release by reviewing and approving product release requests.
• Use judgment to select practical, innovative methods for resolving problems.
• Support business-segment initiatives and applicable Quality Management Systems, Environmental Management Systems, and other regulatory requirements.

Benefits

• Career development opportunities with an international company.
• Eligible employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
• Health and wellness benefits.