Principal Regulatory Affairs Specialist – Vascular (on-site)

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 115000 colleagues serve people in more than 160 countries.

Working 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. Youll also have access to:

• 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 bachelors 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 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.

The Opportunity

Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara CA or Temecula this role you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities including on-market product support product development projects lifecycle management initiatives regulatory assessments and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements evaluating business risks and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies supporting interactions with regulatory authorities and notified bodies and successfully obtaining regulatory approvals for medical devices in the U.S. E.U. and other international markets.

What Youll Work On

• Develop and execute global regulatory strategies to support product changes manufacturing transfers lifecycle management activities new product development and business objectives.
• Independently prepare regulatory submissions and documentation for medical devices.
• Lead regulatory assessments for design manufacturing supplier labeling and process changes to determine global regulatory requirements and submission strategies.
• Review and approve engineering change orders protocols reports specifications risk management documentation validation documents and other project-related records.
• Support and maintain U.S. and international product registrations licenses approvals and technical documentation throughout the product lifecycle.
• Serve as the regulatory lead on cross-functional project teams providing strategic guidance throughout product development and commercialization activities.
• Interpret and apply global regulatory requirements standards guidance documents and industry best practices to support business needs.
• Prepare and maintain FDA submissions including 510(k)s PMAs PMA supplements and other required submissions as applicable.
• Support EU MDR regulatory activities including Technical Documentation updates change assessments and notified body interactions.
• Collaborate with Regulatory Operations Quality Clinical R&D Manufacturing Supply Chain Marketing and other functional groups to ensure timely execution of regulatory deliverables.
• Analyze evolving regulatory requirements and provide recommendations regarding business impact compliance risks and implementation plans.
• Support regulatory authority and notified body inspections audits inquiries and responses.
• Support all company initiatives in accordance with Quality Management Systems (QMS) Environmental Management Systems (EMS) and applicable regulatory requirements.
• Maintain compliance with FDA regulations international regulations company policies procedures and quality requirements.
• Maintain positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
• Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
• May manage direct reports or serve as mentor to other regulatory affairs specialists
• Perform other duties and responsibilities as assigned.

Required Qualifications

• Bachelors Degree in Scientific discipline e.g. Chemistry life Sciences Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for Pharmaceutical In vitro diagnostic devices and/or medical devices.
• Experience of working within the requirements of 21 CFR 820 ISO 13485 the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

PreferredQualifications

• 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
• Regulatory affairs professional experience supporting medical devices.
• Experience leading regulatory activities for cardiovascular endovascular peripheral vascular implantable catheter-based or other complex medical device technologies.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
• Has a strong attention-to-detail
• Strong written verbal presentation and organizational skills as well as analytical and problem-solving skills.
• Working knowledge of QSR ISO and EN standards. Strong working knowledge of regulatory requirements for US EU (EU MDR) and other international geographies.
• Experience authoring and submitting Traditional Special or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
• Experience supporting EU MDR (2017/745) Technical Documentation change notifications clinical evaluation documentation or notified body interactions.
• Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China Canada Australia or Brazil.
• Experience participating in regulatory authority inspections notified body audits and responses to regulatory inquiries.
• Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
• Experience reviewing clinical data.
• Experience with electronic document management systems (EDMS) product lifecycle management (PLM) systems eQMS platforms and change control processes.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment.
• Experience managing direct reports or dotted line manager to regulatory affairs specialists
• Ability to leverage manage and/or engage others to accomplish projects.
• Applies critical thinking to multitask prioritize and meet deadlines in a timely manner.
• Ability to identify risk areas and escalate issues as appropriate.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

$100000.00 $200000.00

In specific locations the pay range may vary from the range posted.

Regulatory Operations

AVD Vascular

United States > Santa Clara : Building B - SC

United States > Temecula : Building B - TB

Standard

Yes 10 % of the Time

No

Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Staff IC