New · posted Nov 6
Merck · Pharmaceuticals
Specialist, Quality Systems & Compliance
- Rahway, NJ
- Hybrid
- Full-time
- Associate & Specialist
The role
The Specialist, Quality Systems & Compliance in Device Regulatory & Quality, will be responsible for supporting MDCP Complaints team and other DQ&R Systems tasks and priorities as needed. This position will interact with cross-functional teams and sites. Activities will include review of documentation to ensure compliance with applicable Combination Product or Medical Device Regulations and internal of our company's requirements. In addition, the Specialist is responsible for execution of MDCP projects and support of the device data domain.
Primary activities include but are not limited to:
- Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
- Document review/approval in complaint database
- Collaborate with the Site Complaint Investigating Unit and Device -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.
- Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and/or preventive actions are put in place to address external customer complaints
- Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
- Collaborate with Device to update the Device Risk Management files, as needed.
- Review and approve reportable external customer complaint investigation reports prior to their submission to health authority
- Assist with maintenance of MDCP data across our company's IT systems, including but not limited to SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults
- Coordinates, approves as Quality role all creations and changes to SAP master data field ZZMAT_MDCP_ID
- Submits SAP post-approval updates to GCM TW team to complete the same MDCP identifier updates GCM updates
- Maintains SAP access and role mapping for Device Quality & Regulatory Complaints team
- Supports team as LMS training system steward
- Maintains team SharePoint sites
- Maintains MDCPQ mailbox and associated activities
- Maintains metrics and reporting associated with MDCP deviations, changes, CAPAs and complaints
Education/Experience minimum requirement:
- 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
- Required: Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field
What you need
Required Skills
- Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
- A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
- Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to a fast-paced environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.
Preferred experience and skills:
- Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).
- Experience in Complaint Handling investigation process
- Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements).
Required Skills
Adaptability, Complaints Investigation, Creative Thinking, Cross-Functional Teamwork, Detail-Oriented, Problem Solving, Working Independently
Travel Requirements
10%
Pay and benefits
$87,000 – $137,000 a year
Employer providedAdditional location(s) Compensation Information
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick and compassionate days
Annual bonus and long-term incentive eligibility
Where you'll work
Rahway, NJHybridOpen in Maps (opens in a new tab)
More jobs in Rahway, NJWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
Job Posting End Date
11/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$87,300.00 - $137,400.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above the US median for Complaints & Post-Market Quality roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $87,000 | — | $137,000 |
| All US (middle half) | $83,000 | $104,000 | $105,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Complaints & Post-Market Quality roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Complaints & Post-Market Quality
The general path across 28 open Complaints & Post-Market Quality roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA11
- Collaboration and leadership11
- Data and digital systems5
- Documentation and SOPs4
- Quality systems and risk4
- GMP and compliance3
- Regulatory submissions3
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Complaints & Post-Market Quality work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 8
- Locations
By discipline
- Clinical28 62%
- Quality10 22%
- Regulatory7 16%
By level
- Director34 76%
- Associate & Specialist6 13%
- Senior & Principal4 9%
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Specialist, Quality Systems & Compliance at Merck
Applications close November 10. $87K–$137K a year, employer provided.