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Sr Scientist, Post Market Surveillance - 2406214165W

Description

Johnson & Johnson is currently seeking a Sr Scientist, Post Market Surveillance to join our Abiomed Team located in Danvers, MA or Irvine, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes. This role will help create annual reports, enable signal detection, analyze complaint data trending, and escalate trends or issues as needed in accordance with procedural guidance. This individual will present post market data in any forums as necessary (data review board, complaint trending meetings, etc.) This role will also provide support during inspections by regulatory bodies and ensure appropriate post market surveillance information is available and fit for delivery to the front room.

Principle Duties and Responsibilities :

• Subject matter expert accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and presenting PMS data in any required forums.

• Creates and presents post market surveillance data for management review.

• Participates in cross-functional and global teams to execute post market surveillance activities.

• Collaborates with cross-functional partners to investigate relationships between key risk factors, medication, and procedural information and adverse events/complaint rates.

• Collaborates with cross-functional partners to create informative annual reports and other post market surveillance activities when such activities are required as part of the post market surveillance commitments.

• Keeps abreast of current trends in literature and research pertaining to data analysis for complaints / adverse event data.

• Ensures compliance with QSR, MDV, MDR, MPR, and any applicable country regulations and requirements regarding post market surveillance trending.

• Support additional information requests from global regulatory agencies.

• Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations.

• Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.

• Perform other duties as required.

Qualifications

Education and Experience:

• Minimum BS degree with 4-6 years professional experience in the STEM field.

Skills & Competencies

• Experience with fulfilling requests from internal and external audits is preferred.

• Demonstrated expertise in statistical methods.

• Ability to travel 10% domestically and internationally.

• Project management knowledge and understanding.

• Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR.

• Demonstrated ability to create accurate and informative post market surveillance documentation consistent with applicable quality standards.

• Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability.

• Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics.

Please note, there is a pre-identified candidate for the role, however all applications will be reviewed and considered.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

The base compensation for the role is between $90,000-$144,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year

• Holiday pay, including Floating Holidays up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 10/2/24. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Primary Location NA-US-4887-Danvers

Other Locations NA-US-California-Irvine

Organization ABIOMED Inc.(6942)

Job Function Quality Engineering

Req ID: 2406214165W