Job Information
Merck Director, Principal Scientist Device Regulatory Compliance in Frankfort, Kentucky
Job Description
Position Title -Director/ Principal Scientist, Regulatory Compliance
Department - Device Quality & Regulatory
Brief Description of Position-
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:
Lead a cross-functional team to standardize global medical device requirements including US, EU, UK, Switzerland, Canada, Japan, Australia and Brazil
Stay abreast of evolving global regulatory landscapes for medical device and medical device combination products. Support generation of external surveillance reports of new and revised regulations, final guidance and standards.
Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback and global regulatory trends.
Collaborate with GRACS, Device, Development & Technology (DD&T), purchasing, and manufacturing quality teams to ensure regulatory requirements are integrated into product development and manufacturing processes.
Develop implementation strategies to align the QMS with identified regulatory updates.
Supports device sites with the collection and analysis of data for management review.
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
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 -
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
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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US and Puerto Rico Residents Only:
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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:
$181,600.00 - $285,800.00
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 (https://www.benefitsatmerck.com/) .
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Remote
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/7/2024
*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.
Requisition ID: R318412
Merck
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