Lifenet

Sr. Regulatory Affairs Specialist

Lifenet • $80K — $110K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Life Sciences, Engineering or related discipline
  • 5 years of experience in Regulatory Affairs, preferably in the medical device industry
  • Experience in FDA, EU, Health Canada, Brazil, Japan, and Australia registrations
  • Exceptional oral and written communication ability
  • Demonstrated organizational skills and attention to detail
  • Familiarity with electromechanical and implantable medical devices preferred

Responsibilities

  • Author and submit 510(k) applications, PMA Supplements, and Technical Documentation
  • Maintain Technical Files in compliance with MDD 93/42/EEC and EU MDR 2017/745
  • Communicate with Regulatory Agencies on submissions and product changes
  • Serve as Subject Matter Expert for internal and external regulatory audits
  • Collaborate on cross-functional teams for specific projects
  • Review scientific protocols and reports for compliance and validity
  • Conduct Regulatory Assessments for changes to design, manufacturing, and labeling

Benefits

  • Opportunity to work with a diverse range of regulatory environments
  • Hands-on experience with both new product approvals and renewals
  • Position offers visibility as a Subject Matter Expert during audits
  • Collaboration with cross-functional teams broadens professional experience
  • Potential for involvement in cutting-edge projects within medical devices
Full Job Description
The Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. The Sr Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures.What you'll be doing
  • Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.
  • Author and maintain Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.
  • Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development.
  • Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies.
  • Participate on cross-functional teams for projects as assigned.
  • Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.
  • Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.
  • Research requirements and set priorities while maintaining project schedules.
  • Provide guidance and oversight to team members related to regulatory compliance.
  • Reviewing marketing literature for compliance with applicable regulations and company policies and procedures.
  • Execute additional responsibilities as defined by management.


What you bring to the table

  • Bachelor's Degree in Life Sciences, Engineering or other related discipline.
  • 5 years of experience in Regulatory Affairs, preferably in the medical device industry.
  • FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience.
  • Ability to develop clear, concise, and timely oral and written communication and reports.
  • Excellent communication skills, oral and written, with all levels of personnel.
  • Must be detail oriented and possess considerable organizational skills.
  • Experience with electromechanical and implantable medical devices and human tissue regulations is desirable.
  • Ability to effectively partner with employees, management, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company.


Apply now! Hit the "Apply" button to send us your resume and cover letter.

About Lifenet

Air Methods Corporation is an American privately owned helicopter operator. The air medical division provides emergency medical services to between 70,000 and 100,000 patients every year. It operates in 48 states and Haiti, with air medical as its primary business focus. Its corporate headquarters are located in the Denver Technological Center, Greenwood Village, Colorado, in the Denver metropolitan area. The company was founded by Roy Morgan and began air medical operations in 1980. From 1991 to 2017, the company was a publicly traded company under the NASDAQ ticker "AIRM". In 2017, it was acquired by a private equity firm. In 2012, the company acquired its first helicopter tour operations, Sundance Helicopters, in Las Vegas, Nevada. A year later, Blue Hawaiian joined its tourism division. The company has more than 5,000 employees and operates a fleet of approximately 450 helicopters and fixed-wing aircraft.
Learn more about Lifenet
Industry
Healthcare
Founded
1982
* Ladders Estimates

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