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Abbott · 3 days ago

Senior Specialist Regulatory Affairs

Alameda, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $180K/yr

3+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Regulatory Affairs Specialist will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes, review labeling and promotional materials, and support product development and regulatory activities for new digital products.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input

Coordinate RA Ad & Promo activities among internal Regulatory functions and Division cross functional teams. Facilitate development and process discussions toward implementing advertising and promotion improvement processes

Support RA Ad & Promo management ensuring on time department deliverables and developing mitigation plans for any issues that are identified, including Ad & Promo process improvements

Analyze reports and metrics from tracking tools, identifying trends and ramifications

Lead and execute projects that support the strategic direction of Division, working independently or as part of a team

Lead and support projects involving AI-driven solutions, ensuring successful implementation and integration into business processes

Lead junior RA Ad & Promo team members, developing their skills/abilities, verifying work, and assisting them in areas of efficiency and regulatory knowledge

Function as a team lead when RA Management is not available toward prioritizing department workstream and facilitating issue resolution or escalation

Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed

Determine and communicate promotional content and approval requirements to cross functional teams with limited supervision

Assist compliance with product post-marketing approval requirements as needed

Qualification

Regulatory AffairsMedical DevicesAI TechnologiesProject ManagementCommunication SkillsTechnical WritingQuality SystemsOffice ProgramsAnalytical ThinkingAttention to Detail

Required

Bachelors Degree (± 16 years), Related field OR an equivalent combination of education and work experience

Masters Degree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience

Minimum 3 years, 3-4 years experience in a regulated industry (e.g., medical products, nutritionals)

2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

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

Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Regulatory agency structure and processes

Principles and requirements of applicable regulations and agency guidance

Submission/registration types and requirements

GxPs (GCPs, GLPs, GMPs)

Principles and requirements of promotion, advertising and labeling

Ethical guidelines of the regulatory profession

Communication Skills or Ability to: 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

Negotiate internally and externally with regulatory agencies

Cognitive Skills or Ability to: Pay strong attention to detail

Manage projects

Create and maintain project plans and timelines

Think analytically

Organize and track complex information

Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

Has broad knowledge of various technical alternatives and their potential impact on the business

Exercise good and ethical judgment within policy and regulations

Use in-depth knowledge of business functions and cross group dependencies/ relationships

Define regulatory strategy with supervision

Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Preferred

Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements, and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; 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

3+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred

Experience with review of labeling, promotional, and or advertising materials is highly desired

Principles and requirements of promotion, advertising and labeling

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

Office program skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint

Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields

Master's Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience