Director, Principal Scientist Device Regulatory Compliance

Merck Director, Principal Scientist Device Regulatory Compliance Honolulu, Hawaii Apply Now

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:

1. Lead a cross-functional team to standardize global medical device requirements including US, EU, UK, Switzerland, Canada, Japan, Australia, and Brazil.
2. 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.
3. Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback and global regulatory trends.
4. 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.
5. Develop implementation strategies to align the QMS with identified regulatory updates.
6. Support 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

1. Bachelor's degree in a Science, Engineering, or a related field.
2. At least 5 years of experience working in Pharmaceutical, Medical Device, or Biotech Industry.
3. Recent experience interfacing with regulatory agencies such as FDA, EMA, or EU Notified Body.
4. Recent experience participating in Notified Body Audits.
5. Must be proficient in English.

Preferred Skills & Experience

1. Experience performing external surveillance of global device regulations.
2. Experience with authoring and reviewing regulatory submissions.
3. Experience performing gap analysis of quality systems against ISO 13485, MDSAP, EU MDR, EU IVDR, and other global device regulations.
4. Experience obtaining CE Marking for Medical Devices and Notified Body Opinion (NBOp) for drug delivery combination products.
5. Prefer at least 3 years demonstrated leadership experience with project teams.

Employee Status - Regular

Relocation - Not applicable

VISA Sponsorship - Not applicable

Flexible Work Arrangements - Remote

Travel Requirements - Less than 20% travel to US/OUS

Job Posting End Date - 11/7/2024