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 109,000 colleagues serve people in more than 160 countries.

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Our location in SYLMAR, CA currently has an opportunity for a Senior Specialist Regulatory Affairs. This position leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

WHAT YOU’LL DO

• Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.

• Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities in US and Europe.

• Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

• Postmarket: Maintain CE certifications, recurring submissions and EU technical files. Assist compliance with product postmarketing approval requirements.

• Review and approve labeling, advertising and promotional items to ensure regulatory compliance. Assess external communications relative to regulations. Assist with label development and review for compliance before release.

• Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.

• Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications with supervision.

• Medical writing, Advertising and promotion, Labeling, Controlled substances, Restricted substances (e.g. REACH), Compendial / standards, Import / export, Country specific regulatory support.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelors Degree in a related technical or science field

• Minimum 5 years of Technical experience, including at least 4 years of regulatory experience in a medical device industry.

• Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.

• Expertise with EDMS (Documentum based), publishing and or registration management systems, Adobe Acrobat or demonstrated experience with similar tools.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Ability to leverage and/or engage others to accomplish projects.

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

• Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

Preferred

• 5+  yrs experience in a regulated industry (e.g., medical products, combination products). 3-4 years of experience in regulatory preferred but may consider engineers, quality assurance, research and development/support, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Expertise with electronic submission formats like eCTD, ACTD and NeeS.

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

• Submission/registration types and requirements related to IDE, PMA, 510(k) and EU MDR GxPs (GCPs, GLPs, GMPs).

• Principles and requirements of promotion, advertising and labeling.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• 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

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com