Regulatory Affairs Manager - Neuromodulation (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 114,000 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. You'll also have access to:

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

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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.

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Opportunity

Our Plano or Austin, Texas locations, currently have an on-site opportunity for a Regulatory Affairs Manager . This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programs.

What You'll Work On

• Develops sound global regulatory strategies for new and modified medical devices.

• Compiles, prepares, reviews, and submits robust regulatory submissions to world-wide authorities to achieve departmental and organizational objectives.

• Identifies key areas of regulatory risk and probabilities of occurrence. Develops mitigation strategies and ensures implementation and follow up.

• Independently interacts and builds partnerships with external regulatory authorities such as FDA, European notified bodies, etc.

• Provides leadership and guidance to other members of the RA staff as well as to cross-functional team members and development teams.

• Drives cross functional alignment with issues that could have Regulatory ramifications.

• Builds strategic partnerships to further departmental and organizational objectives.

• Reviews and approves preclinical, clinical and manufacturing changes for compliance with applicable regulations and evaluates appropriate regulatory filing strategies.

• Reviews device labeling and marketing materials for compliance with FDA and world-wide submissions and applicable regulations.

• Anticipates regulatory obstacles and emerging issues, including new and proposed regulations, throughout the product lifecycle and develop solutions with other members of regulatory and cross-functional teams.

• Develops, implements, and manages regulatory SOPs, processes and systems as needed.

• Monitors, evaluates, and interprets applicable regulatory requirements, assures compliance with Abbott policies and external requirements and standards.

• Plans and manages complex projects and prioritizes workload.

• May manage regulatory budget at team or project level.

• May provide direct or indirect supervision of individuals including mentoring, performance management and staffing decisions.

• May develop team or department goals and objectives in alignment with regulatory strategy and business objectives.

• Assist with audits and inspections, as needed.

Required Qualifications

• Bachelor's Degree OR an equivalent combination of education and experience

• 8+ years technical experience

• 6+ years medical device regulatory experience. Extensive experience with US and global medical device regulations and submissions.

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

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.

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

• Multi-tasks, prioritizes and meets deadlines in timely manner.

• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Preferred Qualifications

• Bachelor's degree in technical discipline

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

• Experience acting as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team

• Experience acting 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.

• Experience supporting audits by regulatory agencies, including GMP, ISO13485, and FQA audits.

• Ability to oversee multiple projects in a matrix team environment.

• Ability to work effectively in multinational/multicultural environment.

• Excellent oral and written communication and presentation skills

• Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.

• Ability to lead, coach and motivate others.

• Ability to accomplish results through others.

Apply Now (~~~)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

Connect with us at ~~~ , on Facebook at ~~~/Abbott and on Twitter @AbbottNews.Connect with us at ~~~ , on Facebook at ~~~/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $95,000.00 - $190,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call ~~~ or email ~~~