Principal Regulatory Affairs Specialist - Diabetes Care (on-site)

About the role

The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We're focused on helping people with diabetes manage their health 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.

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Write and edit technical documents.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Review and approve labeling to ensure compliance.
• Monitor emerging issues and identify solutions.
• Negotiate internally and externally with regulatory agencies.
• Evaluate regulatory risks of corporate policies.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post-marketing approval requirements.
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
• Actively contribute to the development and functioning of the crisis/issue management program.
• Analyze product-associated problems and develop proposals for solutions.
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.

Requirements

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for Combination Devices, 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).

Preferred Qualifications

• 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs.
• Regulatory Affairs Certification (RAC) is a plus.
• Experience with either 510(k) applications, PMA supplements, US Device regulations, or with EU and other international medical device regulations and submissions.
• Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines.
• Experience with word processing, spreadsheet and presentation graphic software packages.
• Experience working in a broader enterprise/cross-division business unit model.
• 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.
• Ability to identify, solve problems, and work independently with little oversight.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5%, including international travel.

Benefits

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

Contact Us

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Pay

The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.