Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance

Merck; Rahway (NJ); Remote; USD 139,000 - 220,000; Full time

Job summary

Join a leading company dedicated to compliance and quality in medical devices. This role involves ensuring regulatory adherence for a diverse portfolio, engaging with cross-functional teams to maintain high standards in device quality management. Bring your expertise in regulatory submissions and quality systems to deliver impactful solutions.

Benefits

Comprehensive health benefits

401(k) retirement plan

Paid holidays and vacation

Qualifications

• At least 5 years of experience in Pharmaceutical, Medical Device or Biotech.
• Experience with FDA, EMA, and EU Notified Bodies.
• Leadership experience with project teams preferred.

Responsibilities

• Ensure regulatory compliance for medical devices and combination products.
• Support inspections and manage quality system initiatives.
• Collaborate with teams to integrate regulatory requirements into QMS processes.

Skills

Detail-Oriented

Regulatory Compliance

Regulatory Affairs

Education

Bachelor's degree in Science, Engineering or related field

Tools

Regulatory Quality Systems

eCTD

Veeva

Job description

Job Description

This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices and medical device combination products.

Primary activities include, but are not limited to:

• Serve as coordinator for management review of the company's device quality management system, including working with sites to collect, analyze and summarize data for management review meetings and presentations.
• Support device related internal, notified body and health authority inspections
• Provide support for quality system initiatives by generating, managing, and tracking gap assessments, quality plans, and CAPA
• Collaborate with global IT organizations to ensure medical device and medical device combination quality system aspects are integrated
• Stay abreast of evolving global regulatory landscapes for medical device and medical device combination products.
• Collaborate with GRACS, Device, Development & Technology (DD&T), purchasing, and manufacturing quality teams to ensure regulatory requirements are integrated into applicable QMS processes.
• Develop implementation strategies to align the QMS with identified regulatory updates.
• Audit vendors/partners of SaMD/IVD/Companion Diagnostics

Reports to - Director Regulatory Compliance, Device Quality and Regulatory

Location - Remote, Preference would be to work from Rahway, NJ, Upper Gwynedd, PA.

Extent of Travel -Less than 20% travel to US/OUS

Qualifications, Skills & Experience -

• Bachelor's degree in a Science, Engineering, or a related field
• At least 5 years of experience working in Pharmaceutical, Medical Device or Biotech Industry
• Demonstrated experience managing quality system dashboards
• Recent experience interfacing with regulatory agencies such as FDA, EMA, or EU Notified Body
• Recent experience participating in Notified Body Audits
• Must be proficient in English

Preferred Skills & Experience -

• Demonstrated proficiency in the use and enhancement of quality related IT systems (e.g. Veeva, Qlik Sense etc.)
• Experience performing external surveillance of global device regulations.
• Experience with authoring and reviewing regulatory submissions.
• Experience performing gap analysis of quality systems against ISO 13485, MDSAP, EU MDR, EU IVDR and other global device regulations.
• Experience obtaining CE Marking for Medical Devices and Notified Body Opinion (NBOp) for drug delivery combination products.
• Prefer at least 3 years demonstrated leadership experience with project teams

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

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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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$139,600.00 - $219,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Applied Engineering, Biologics License Application (BLA), Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Medical Device Regulations, International Regulatory Compliance, Management Process, Manufacturing Compliance, Mechatronics, Medical Device Quality Systems, Medical Devices, Pharmaceutical Process Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Requirements, Regulatory Strategy Development, Regulatory Submissions, Regulatory Writing

Preferred Skills:

Job Posting End Date:

07/8/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R354271