Regulatory Affairs Manager

1 month ago

Pleasanton, United States Mastech Digital Full time

Position: HIM Director(Regulatory Manager)

Location: Pleasanton CA 94588 (4 days a week)

Duration: 12+ Months (Possibility to extend/Convert)

Pay: $70-80/hr on W2

Visa: Only Citizen and Green Card




Please do not apply if you have already applied for Job ID's KAISJP00228917 & KAISJP00224137

Hiring Manager has rejected all the candidate submitted for above Job Id's



Recent rejection and hiring manager note

Didn't understand hospital workflow (people who have interviewed). When doing regulatory and quality- candidates are looking at it like a manufacturing product (product are looking at defects)- It's not a product Quality monitoring (doc is following regulations)- Gray area work within.. More whole picture instead of just by the book. Monitoring hospital data (what do you look for in the data). What are major issues that sites have for compliance (how to break it down specifically)


Regulatory- Subject Matter Expert (knowing the rules/regulations. Interpret the rules to satisfy or to satisfy the other individuals ideas on the team. Without breaking anything or dismissing. Gotta have compromise (staying within regulation)


Contractor- Worked with groups (have not developed a team) They have always been together. Did you specifically teach people in your previous roles (what are the examples).


Still FTE- They have everything cultural fit.

Still Onsite- Pleasanton 4 days a week (hybrid)


Too much Manufacturing. More knowledge/understanding hospital setting. Did conducting clinical studies or hospital settings is a huge plus.


Taken - ACRP/ SOCRA Certifications or classes is a +


Overviews- Think on their feet. Street Smarts (not all book smart). Big picture view.





Required Qualifications:

● Bachelor's degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two years of experience

● Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines

● Minimum five years in a quality management role with direct reports

● In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems

● Demonstrated experience identifying areas for improvement and implementing solutions; ensuring compliance with standards, regulations and company procedures; and

● administering successful programs within appropriate timelines

● Experience conducting training for quality assurance and/or regulatory affairs

● Ability to interact positively with all levels of staff and external contacts

● Proficiency in Microsoft Word, Outlook, Excel and PowerPoint

● Excellent verbal and written communication skills

● Experience adopting a flexible, proactive, and service-oriented approach

● Travel may be required




Desired Knowledge, Skills and Abilities:

● Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred

● Experience with on-site monitoring

● Expert planning and organization skills

● Strong attention to detail

● Exceptionally team focused; actively contributes to a positive and innovative work

● environment

● Able to demonstrate the highest ethical standards; promotes trust, respect and integrity

● Spanish language skills a plus

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