Makro Scientific: Life to Life for Better Life.

Makro Scientific: Staffing Specialist in Clinical and Scientific.

Job Order ID: LIB- 26254.
Job Title: Principal Regulatory Affairs Specialist.
Location: Pittsburgh, PA.
Job Type: Fulltime Permanent.

Job Description:

• The Principal Regulatory Affairs Specialist will provide World-wide Regulatory leadership to the client’s Interventional Pittsburgh (MIP) organization.

This leadership will be keenly focused on the following:

• Developing effective business/balanced regulatory assessments and strategies in support of new product initiatives and product line extensions.
• Coordinating clinical studies of new and/or modified devices and/or claim expansion activities.
• Preparing regulatory submissions (510(k), PMA) to secure FDA marketing clearance.
• Meeting and aligning with regulatory bodies in the early stages of NPD to ensure effective path to market.
• Preparing Technical Files and Design Dossiers in compliance with the European Medical Device Directives with interaction with Notified Bodies.
• Preparing and coordinate regulatory submissions for all areas of the world (Asia/Pacific, the Americas.
• Educating the organization on and review and approve of regulatory aspects of product labeling and marketing literature.
• Monitoring changes to domestic and international regulations and standards.
• Challenges will be balancing business regulatory compliance with company’s competitive position, staying abreast of the ever-changing regulatory environment, broad yet deep knowledge requirements, and the ability to complete extensive day-to-day regulatory documentation.

Technical/Behavioral Requirements:

• Bachelor’s degree in a science (BS) or technical arena (preferably engineering) is required.
• Twelve plus (12+) years overall experience in a regulated industry, required with ten (10) years in the medical device industry preferred.
• Five (5) years experience developing and leading regulatory submissions, registrations, technical files, etc. is required.
• Strong working knowledge of QSRs and other applicable FDA regulations; specifically Design Controls is required.
• Experience with ISO9001, ISO 13485, CE marking requirements, and MDD required.
• Experience with General Principals of Software Validation and ISO14071, and Risk Management ISO14971 is required.
• One (1) to three (3) years experience in conducting and monitoring clinical trials preferred.
• Experience working in an FDA-regulated environment for software controlled electromechanical devices or sterile disposable is preferred.
• RAPS Regulatory Affairs Certification (RAC), preferred. 

Candidates Must Have:

• 5 years developing and leading submissions, registrations, filings.
• Knows QSRs, FDA regs and Design Controls.
• Experience working with FDA for a medical device manufacturer.

Location: Pittsburgh, PA.
Job Type: Fulltime Permanent.

Contact: Ismail

The best telephone number to reach me is 973-481-0100 Ext: 3044. OR Fax: 973-481-1020 I appreciate if you forward your updated word formatted resume at /ismail.bepari@makrotech.com for review before we speak.

For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005 or E-mail your resume at recruiter@makrotech.com. We shall be happy to help you.