Senior Medical Writer, Clinical Evaluation
Abbott
Assembly
Senior Regulatory Affairs Specialist, Electrophysiology
Abbott
full-time
Posted on:
Location Type: Office
Location: Plymouth • Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $75,300 - $150,700 per year
Job Level
Senior
About the role
- Lead preparation and submission for regulatory approvals and identify and resolve problems.
- Provide regulatory guidance to cross-functional partners in support of various programs.
- Prepare robust regulatory applications to achieve departmental and organizational objectives.
- Act as a regulatory representative on core product development teams; communicate regulatory requirements and impact of regulations to the development team.
- Compile, prepare, review and submit medical device submissions to regulatory agencies.
- Interface directly with FDA and other regulatory agencies; act as liaison between the Company and regulatory agencies.
- Maintain ongoing surveillance and analysis of domestic and international medical device regulations; ensure submission requirements are current and entered into regulatory submission database and file systems.
- Review device labeling for compliance with FDA submissions and applicable regulations.
- Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Conduct reviews of product and manufacturing changes for compliance with applicable commercial and clinical regulations.
- Support business segment initiatives and Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) and international regulations, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Provide mentoring and leadership to other Regulatory team members.
- Travel up to 5% of the time.
Requirements
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
- Preferred: 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry.
- Preferred: Advanced level degree.
- Preferred: Class II or Class III medical device experience.
- Preferred: Experience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions.
- Preferred: Experience with risk management, design verification, or process validation work.
- Proficient with MS Office suite (Word, Excel, Outlook).
- Previous experience working in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Benefits
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit (affordable path to bachelor\'s degree).
- Health and wellness benefits (see www.abbottbenefits.com).
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsmedical device regulationsPMA supplements510(k) applicationsrisk managementdesign verificationprocess validationregulatory guidancequality management systemsenvironmental management systems
Soft skills
communicationleadershipmentoringcollaborationproblem-solvinginterpersonal skillsorganizational skillscross-functional teamworkpositive communicationadaptability
