Sr Director regulatory Affairs
Tewksbury, MA 01810 US
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Title: Sr Director of Regulatory Affairs
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $200-230K
- Job Location: Tewksbury, MA
- Job# 14982
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES INCLUDE:
- Develop and implement strategies and tactics to obtain FDA and international regulatory approvals of Class III marketing applications and clinical trial applications in the US and around the world.
- Prepare and review regulatory submissions for the FDA and international agencies and notified bodies, including original IDE and PMA applications, supplements and reports as well as Technical Files and reports for EU MDR certification and other international registrations.
- Serve as contact person for regulatory submissions with FDA and international regulatory authorities
- Recruit, manage and mentor junior RA staff members to form a high-performance RA team that can efficiently manage and complete regulatory projects in the US and globally.
- Responsible for working with Quality and Operations on changes to products and manufacturing processes and serve as regulatory lead in devising strategies to ensure compliance with US and international requirements
- Serve as regulatory lead for FDA and notified body audits for MDR, MDSAP, and QSR and BIMO compliance
- Establish effective communication with executives and managers to ensure that company objectives and milestones are met, consistent with regulatory requirements
- Enhance and sustain positive relationships with the FDA and other international regulatory agencies and notified bodies
- Review and interpret regulatory rules as they relate to company procedures, clinical studies, engineering testing, and documentation and ensure that they are communicated through company policies and procedures
- BACKGROUND AND QUALIFICATIONS:
- Minimum 12+ years regulatory experience in the medical device industry. Experience with Class III medical devices and experience with EU MDD/MDR required. Experience with Class III cardiovascular devices a plus.
- Minimum of 5 years management experience required.
- Solid experience and proven track record in successful international and FDA submissions including IDE and PMA applications, supplements and reports and EU MDD/MDR Technical Documentation and reports.
- Proven track record of exercising independent judgment and driving regulatory projects to successful conclusion
- Proven project management and leadership skills
- Must be hands on with demonstrated strong organizational skills
- Must have strong interpersonal skills and ability to communicate ideas and information clearly, effectively and frequently (oral and written)
- Demonstrated ability with analytical and decision-making skills
- Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities
• BS in Engineering, Life or Biological Sciences, or related field; MS or PhD preferred
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