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Abbott · 1 month ago

Regulatory Affairs Specialist II

Pleasanton, CA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Regulatory Affairs Specialist II to support the regulatory department in ensuring efficient and compliant business processes. The role involves preparing and submitting documentation for worldwide product registration and maintaining communication with regulatory agencies.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations

Prepares robust regulatory applications to achieve departmental and organizational objectives

Represents RA on cross-functional product development and manufacturing support teams

Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail

Maintains ongoing surveillance and analysis of all pertinent international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

Interfaces directly with regulatory agencies as needed

Conducts reviews of product and manufacturing changes for compliance with applicable regulations

Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities and notified-bodies

Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Complies with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Qualification

Regulatory submissionsRegulatory guidelinesTechnical documentationProject managementCross-functional collaborationAnalytical thinkingCommunication skillsAttention to detailNegotiation skillsOrganizational skills

Required

Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience

Master's Degree (± 18 years), Preferred

Minimum 2 years This position does not require previous regulatory experience. 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

Experience with 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. Note : This knowledge may be developed through tenure in this position

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

Negotiation skills

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

Has a sound knowledge of a variety of alternatives and their impact on the business

Apply business and regulatory ethical standards

Preferred

Bachelor's degree in a technical discipline

3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry

Familiar with relevant US/ EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations

Proficient with MS Office suite (Word, Excel, Outlook)

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Advanced level degree

Previous experience working in a highly matrixed and geographically diverse business environment

Benefits

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match