Regulatory Affairs Manager – Heart Failure (on-site)

Abbott • Pleasanton, CA

8d • Onsite

About The Position

The Regulatory Affairs Manager role within Abbott's Heart Failure Division is responsible for combining scientific, regulatory, and business knowledge to ensure products meet required legislation. This individual will have department/group/site level influence and serve as an expert resource, potentially sharing knowledge with others. Key functions include identifying, obtaining, and presenting data for worldwide product registration. The role requires anticipating regulatory obstacles, leading functional groups in preparing submissions, and interpreting/applying regulatory requirements. Communication, negotiation with regulatory agencies, and clear articulation of regulatory plans to senior leaders are essential. The position also involves strategic thinking, risk assessment, problem-solving, and managing complex projects in a fast-paced, changing environment.

Requirements

• Bachelor’s Degree in a technical discipline or an equivalent combination of education and experience.
• Minimum 6 years Regulatory experience.
• 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.
• 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.
• Ability to work independently with no oversight.
• Ability to identify and solve problems in a strategic manner.
• Ability to manage complex projects.
• Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.

Nice To Haves

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Advanced degree.
• 8 years’ Regulatory experience.
• Experience working in a broader enterprise/cross-division business unit model.
• Demonstrated experience at a supervisory/managerial level.
• Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Responsibilities

• Anticipate regulatory obstacles and emerging issues.
• Lead functional groups to complete a regulatory submission.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Communicate and work with people from various disciplines and cultures.
• Negotiate internally and externally with regulatory agencies.
• Plan and conduct meetings.
• Work with cross-functional teams.
• Clearly explain and articulate Regulatory plans to Senior leaders.
• Define regulatory strategy.
• Perform risk assessment or analysis.
• Juggle multiple and competing priorities.
• Think analytically with good problem-solving skills.
• Organize and track complex information.
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Influence others to a win/win resolution, appreciating all perspectives.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
• Provides leadership by communicating and providing guidance towards achieving business objectives.
• Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• May lead a cross-functional or cross-divisional project team.
• Provides technical leadership to business units.
• Exercises judgment independently.

Benefits

• 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 an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager