Regulatory Compliance Director

4 weeks ago

Rahway, New Jersey, United States Merck Sharp & Dohme (MSD) Full time
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.

Key Responsibilities:

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.

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.

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.

Merck Sharp & Dohme (MSD) is an equal opportunity employer committed to diversity and inclusion. 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.

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.

Merck Sharp & Dohme (MSD) is 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 and EEOC GINA Supplement.

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