Job Description

*W2 ONLY*

Sr. Regulatory Affairs Specialist (12 month contract // Boulder, CO or Minneapolis, MN):

Candidate is required to work on site in Boulder, CO or Minneapolis, MN at least 3 days per week

Open to fully remote for strong candidates

HM's Top Needs:

1. Experience with US and EU change assessments
2. Experience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author)
3. Willingness to be adaptive, collaborative, and supportive of the Regulatory team

Education/Experience Required: Bachelor’s with 4+ years’ experience in RA, advanced degree with 2+ years’ experience in RA

Duties:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have:

• 2-4+ years’ experience in regulatory (medical devices)
• Strong experience with change assessments for EU/US marketed products
• Strong organizational skills to manage multiple projects simultaneously under limited supervision
• Analytical thinking to identify potential regulatory issues and develop effective solutions.
• Demonstrated excellent organizational skills
• Demonstrated technical writing skills
• Excellent attention to detail
• Excellent communication skills
• Experience as regulatory lead in core teams for sustaining and development projects
• Expert proficiency in Microsoft Office suite, including Word and Excel
• Proficient at managing multiple projects at once
• Regulatory assessment of change orders emphasis on US and EU
• Familiar with ISO 13485, FDA Medical Devices Part 820, and Medical Device Good Documentation Practices

Nice to Have

• 510(k) authorship
• Adobe software skills
• RAPS Regulatory Affairs Certification (RAC)

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