New · posted Nov 1
Abbott · Medical Devices
Senior Medical Writer / Senior Project Manager, Clinical Evaluation
- Santa Clara, CA +1 more
- On-site
- Full-time
- Senior & Principal
The role
We are seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join Abbott’s Vascular Division on-site in Santa Clara, CA or Maple Grove, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
The primary function of a Senior Medical Writer / Senior Project Manager, Clinical Evaluation is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, MDCG Guidance documents, and EU MDR 2017/745.
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 122,000 colleagues serve people in more than 160 countries.
What you need
Required Qualifications
- A college degree (Bachelor’s) is required.
- Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.
- Must have thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
- Project management experience.
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
- Strong command of medical and surgical terminology.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Proven ability to deliver high-quality work within tight timelines.
- Highly-developed interpersonal skills, and strong attention to detail.
- Able to travel as needed (<10%).
Preferred Qualificationsnice to have
- Master’s Degree, RN, PharmD, PhD, or MD preferred.
- 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
- 3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
- Knowledge of Cardiovascular devices and technologies.
What you'll do
What You'll Work On
- Independently creates and maintains Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance [SSCPs], Regulatory Responses and other related documentation.
- Identifies, evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
- Creates, manages, or participates in timelines of deliverables by using appropriate project management tools.
- Clearly and timely communicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers.
- Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
- Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
- Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
- Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
- Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
- Function independently as a decision-maker on CER-related regulatory issues.
- Execute projects within budgetary guidelines.
Pay and benefits
$90,000 – $180,000 a year
Employer providedThe base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage option (HIP PPO plan)
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Santa Clara, CA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: St. Paul, MN
More jobs in Santa Clara, CA +1 moreWorking conditions
Standard
TRAVEL
Not specified
MEDICAL SURVEILLANCE
Not Applicable
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
JOB FAMILY
Medical Writing
DIVISION
MD Medical Devices
LOCATION
United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
From the posting
About Abbott
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
- 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Senior & Principal roles in California5 roles publishing pay
Senior & Principal roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $180,000 |
| California (middle half) | $135,000 | $140,000 | $207,500 |
| All US (middle half) | $131,125 | $146,000 | $178,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Documentation and SOPs5
- Regulatory submissions5
- Quality systems and risk4
- Clinical trial conduct4
- GMP and compliance2
- Lab testing and methods2
- Investigations and CAPA2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Abbott on Regulatory Jobs
- 108
- Open roles
- 98
- Distinct roles
- 32
- Locations
By discipline
- Quality61 56%
- Regulatory30 28%
- Clinical16 15%
By level
- Senior & Principal50 46%
- Associate & Specialist33 31%
- Manager21 19%
More roles at Abbott
- View role
Senior Project Manager, Clinical Evaluation
Sylmar, CAManagerMedical Devices$90K–$180K
- View role
Clinical Trial Associate I
Madison, WIAssociate & SpecialistMedical Devices$51K–$101K
- View role
Clinical Affairs Rotational Excellence (CARE) Program Associate
Maple Grove, MN +2 moreAssociate & SpecialistMedical Devices$78K–$156K
- View role
Manager, Clinical Data Review
Maple Grove, MNManagerMedical Devices$99K–$199K
Similar Clinical Evaluation & Medical Writing roles elsewhere
- View role
Senior Medical Writer
DanaherIrvine, CASenior & PrincipalMedical Devices$130K–$150K
- View role
Clinical Scientist
IntuitiveRemote, USSenior & PrincipalMedical DevicesSalary not listed
- View role
Sr. Medical Writer
Globus MedicalAudubon, PASenior & PrincipalMedical DevicesSalary not listed
- View role
Senior Medical Writer
ArtivionKennesaw, GASenior & PrincipalMedical DevicesSalary not listed
Senior Medical Writer / Senior Project Manager, Clinical Evaluation at Abbott
Open until filled. $90K–$180K a year, employer provided.