Regulatory Affairs Project Manager

Job Description

Job Description

The Regulatory Affairs Project Manager can heavily influence the Company's compliance with product registration requirements. Compliance with Quality System Regulations and standards with respect to following Good Manufacturing Practice and Good Documentation Practice. The perception of regulators about the level of competence of BioHorizons with respect to responsiveness to requests for information and the understanding of U.S. and international regulations.

Essential Duties and Responsibilities:

• Directing and assisting company product registration efforts globally in collaboration with product development teams with a strong focus on US FDA and EU MDR 2017/745 regulations.
• Mentor regulatory affairs team on domestic and EU market strategy and regulatory activities
• Monitor state of the art domestic and international product and quality system regulatory requirements for company impact and report to regulatory management
• Review product registration SOP processes and recommend company compliance improvements to maintain state of the art
• Document, release, and communicate internal and external changes to regulatory affairs policies and procedures to internal cross-functional stake holders.
• Provide strategic regulatory input to product lifecycle planning and assist in the development of regional regulatory strategy
• Execute and document regulatory impact assessments and regulatory reporting as part of change control
• Continue to monitor and compare regulatory outcomes with initial product concepts to make recommendations on future actions
• Determine and communicate submission and approval requirements
• Contribute to post market surveillance reporting requirements and participate in risk benefit analysis for regulatory compliance
• Assess the acceptability of quality, preclinical, and clinical documentation for submission filing
• Compile, prepare, review, and submit regulatory submission to authorities
• Monitor applications under regulatory review and communicate directly, both written and verbally, with FDA reviewers and Notified body auditors, as needed
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Develop and report KPIs for regulatory activities
• Other duties as assigned

Qualifications:

• Sense of ownership and pride in your performance and its impact on the company's success.
• Strong ability to prioritize and handle multi-faceted project management.
• Ability to meet deadlines, balance multiple priorities and effectively prioritize work
• Extremely organized and detail oriented.
• Outstanding communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Education and Experience:

• Bachelor's Degree required and/or combination of experience
• 6-8 years minimum experience in a medical device (U.S. FDA-regulated and registered)
• Manufacturer or Specification Developer in the U.S. and/or foreign regulatory submissions required.
• Experience with FDA pre-market submissions (Q-Sub, 510(k), etc.) required
• Experience with CE marking, including EU MDR technical documentation and Notified Body Audits

Benefits:

• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• Vision Benefits
• Company paid Dental Insurance for employees and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.