Senior Specialist, Global Regulatory Affairs Project and Document Management - Military Veterans

Job Description

Summary, Focus and Purpose
The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with responsibilities supporting the commercialization and sustainment
of medical devices and combination products globally.
• Experience in design controls, device risk management, medical device, complex combination product kits, prefilled syringes, autoinjectors, and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Senior Engineer will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication.
• This individual will be expected to function as an independent contributor, supporting global and site-specific projects, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners.
• The key stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.

Key Functions
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Complete all activities with the highest regard for all of our Company divisional and local site procedures for safety, quality, and regulatory compliance
• Understand the big picture, and how activities link to our Company strategy and business goals
• Utilize device risk management tools to build device or combination product risk management programs in development and life cycle management

• Utilize design control experience to develop value-add solutions to customer needs in medical devices and combination products
• Secure early sponsorship and stakeholder alignment for projects and initiatives.
• Operate effectively as a leader in assigned roles
• Demonstrate the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to key stakeholders and sponsors
• Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations
• Lead technical investigations of medical device and combination product needs for commercial products
• Facilitate technology transfer of medical device and combination products from development to commercialization

Education

• Bachelor of Science or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

Experience | Skills | Knowledge

Required
• Five years of relevant experience in medical devices or combination products Experience in design controls, ISO 13485, deviation management, change control, risk management/ISO 14971-2019 and the fundamentals of documentation structure/systems
• Experience with medical device or combination product commercialization, tech transfers, operations support, and materials/components
• Proficiency in project management
• Principled verbal and written communications
• Five plus years in medical device, pharmaceutical or in biotech organizations Five plus years in design control, risk analysis and change control management for medical device or combination products
• Demonstrated technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents
• Experience with autoinjectors or other complex drug-delivery systems and associated prefilled syringe components
• Experience with design verification testing
• Experience in working with medical device suppliers
• Experience with injection molding, device assembly, and/or design for manufacturing
• Experience in commercialization of high-volume medical device or combination products

#eligibleforERP

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:
$114,700.00 - $180,500.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

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:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
03/24/2025
*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.