The Staff Compliance Engineer (Senior Analyst, Enterprise Compliance) will support, maintain, and lead when necessary, the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements.
Leads and maintains the assigned Compliance functions to ensure compliance to applicable regulations and directives.
Participates in site internal audits as a team or lead auditor.
Leads inspection readiness activities and actively participates in conduct of external quality system audits and inspections.
Supports preparation of external audit and inspection responses.
Manages assigned internal and external audit observations to ensure identified gaps are closed in a timely manner.
Connects and collaborates with other region’s compliance teams.
Creates reports and communicates performance against metrics to key stakeholders.
Maintains current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.

A minimum of a Bachelors or equivalent University degree is required.
6 – 8 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry.
Experience leading internal quality system audits.
Position requires proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent interpersonal skills.
Ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
Ability to analyze complex data and integrate multi-disciplinary feedback.
Excellent communication and interpersonal relation skills.
Expertise on the new Quality System Regulations, with the ability to relate these real live issues.
Proven ability to initiate and implement Quality System changes.
Knowledge of quality and manufacturing systems & processes and applicable regulations, (ISO 13485, MDD 93/42/EEC and amendments, MDR, ISO 14971, FDA’s GMP and QSR requirements for medical devices 21CFR part 11, 210, 211, 820, 803, 806, 807, Part 4, Therapeutic Goods (Medical devices) Regulations, ANVISA Resolution RDC 665, CMDR SOR 98-282, Japan MHLW Ordinance No.169 and other applicable regulations, standards).
Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Experience with Microsoft Project is preferred.

Staff Regulatory Compliance Specialist

Key skills