Regulatory Affairs Manager – Vascular (on-site)

Thornton Tomasetti; San Jose (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement plan with high-em

Tuition reimbursement and educationBEN

Job summary

Abbott in Santa Clara, CA is seeking a Regulatory Affairs Manager to combine scientific, regulatory, and business expertise to enable compliant products. The role involves leading regulatory strategy, developing submissions for FDA and international agencies, and guiding cross-functional teams to meet deadlines.

The candidate will work onsite in Santa Clara, CA with responsibilities spanning pre- and post-approval activities and mentoring junior staff within Regulatory Operations.

Qualifications

• Bachelor's Degree in a related field or equivalent education/experience.
• Minimum 4 years’ experience in a regulated industry; 2–5 years in regulatory preferred.
• Ability to communicate effectively with diverse audiences, verbally and in writing.
• Familiarity with domestic and international regulatory guidelines and submissions.

Responsibilities

• Develop regulatory policies, processes and SOPs and train key staff.
• Provide regulatory input to product lifecycle planning and strategy.
• Prepare robust regulatory applications (FDA and international) for submission.
• Lead cross-functional regulatory strategy and manage deadlines and projects.

Skills

Regulatory affairs

Written & verbal communication

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's Degree or equivalent

Job description

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Work at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

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
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

Abbott Vascular

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Role Overview

This Regulatory Affairs Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.

What You’ll Do

• Develop new regulatory policies, processes and SOPs and train key staff on them
• Evaluate regulatory risks of division policies, processes, procedures
• Provide regulatory input to product lifecycle planning
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Support pre and post approval clinical strategy and submission activities
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing
• Compile, prepare, review and submit regulatory submissions to authorities
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Ensure compliance with US and global product post marketing approval requirements
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
• Execute and manage technical and scientific regulatory activities
• Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies
• Properly interpret and apply regulatory requirements
• Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
• Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
• May supervise exempt or non-exempt employees
• May lead a cross-functional or cross-divisional project team
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures

Required Qualifications

Bachelor's Degree in a related field OR an equivalent combination of education and work experience

Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.

Domestic and international regulatory guidelines, policies and regulations.

Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

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

Master’s or Ph.D. in a technical area

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

Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions

Experience with Class II and Class III medical devices

Ability to define regulatory strategy.

Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

Experience with post-approval manufacturing and design changes

Ability to work effectively on cross-functional teams

Strong attention to detail

Experience with organizing and tracking complex information.

Able to juggle multiple and competing priorities

Experience with exercising 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

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

Job Details

JOB FAMILY: Regulatory Operations DIVISION: AVD Vascular LOCATION: United States > Santa Clara : Building B - SC ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Salary and Benefits

The base pay for this position is $114,000.00 - $228,000.00 In specific locations, the pay range may vary from the range posted.

Equal Opportunity & Diversity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Company Vision

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.