Senior Regulatory Affairs Specialist, APAC

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.

At Abbott Diabetes Care, we believe people with diabetes should have the freedom to enjoy active lives.

That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions.

We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our Division Headquarters in Alameda, CA currently has a hiring opportunity for a Senior Regulatory Affairs Specialist for the APAC region.

This is an opportunity to work and collaborate with technical teams (R&D) and marketing teams while building international regulatory strategies.

This Sr.

Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment within the APAC region.

The individual has responsibility and participation in the registration of products by preparing and submitting documentation needed for registration worldwide.

This Senior Regulatory Affairs Specialist position at ADC will focus on regulatory affairs submissions and change management for our next generation sensing products.

Regulatory affairs submissions experience, US or international, or a background in software products is preferred, as well as project management skills.

The function of this role is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

May play a consultative role by partnering across business functions, contract manufacturers, and suppliers.

This individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the submission, clearance and registration of products worldwide.

The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

This is a broad scoped position with strong opportunity for growth and career development.

WHAT YOU WILL DO 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.

Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

Determine trade issues to anticipate regulatory obstacles.

Determine and communicate submission and approval requirements.

Participate in risk benefit analysis for regulatory compliance.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

Compile, prepare, review and submit regulatory submission to authorities.

Monitor impact of changing regulations on submission strategies.

Monitor applications under regulatory review.

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.

Assist compliance with product post marketing approval requirements.

Review regulatory aspects of contracts.

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.

Provide regulatory input for product recalls and recall communications.

EDUCATION AND EXPERIENCE YOU’LL BRING At least three (3) years of regulatory affairs experience within medical devices (preferred) or pharma.

FDA/EU or international regulatory experience is required.

Bachelors degree (or equivalent Education/Experience) is required.

Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: A fast-paced work environment where your contribution is essential to success 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 Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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

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