Regulatory Affairs Specialist - Medical Devices

To Discuss more about this job opportunity, please reach out to Deepak Arya LinkedIn URL www.linkedin.com/in/deepak-arya-8a79aa22a email your updated resume at Email deepak.arya@collabera.com . Thank you!

Pay Range:

$38 to $43 per hour

Industry:

Pharmaceutical Work Type:

Onsite Contract Duration:

12 Months (Possibility of Extension)

Job Summary:

We are seeking an experienced Regulatory Affairs Specialist to support regulatory strategy and execution for high risk implantable medical devices in a regulated environment. The role involves preparation and submission of regulatory filings along with ensuring compliance with FDA regulations and quality systems. The candidate will collaborate with cross functional teams to review technical and manufacturing changes while maintaining regulatory alignment. This position requires strong expertise in PMA submissions and labeling activities along with the ability to manage complex regulatory processes independently. The ideal candidate will bring deep knowledge of Class III devices and a proactive approach to regulatory compliance and submissions.

Key Responsibilities:

Prepare author and submit PMA supplements and regulatory filings in alignment with regulatory requirements Manage regulatory labeling updates including addendum and supplemental labeling changes Interface with regulatory authorities for submissions responses and inquiries Review and approve engineering and validation study protocols and reports Assess and approve manufacturing changes for regulatory impact and compliance Collaborate with quality engineering and manufacturing teams to ensure regulatory alignment Ensure compliance with FDA regulations and internal quality systems Provide regulatory guidance to project teams and support regulatory strategy execution

Required Qualifications:

5 years of experience in Regulatory Affairs Hands on experience with regulatory labeling including addendum supplemental or labeling changes Experience in regulated medical device environments and quality systems Strong experience with Class III implantable medical devices Proven experience authoring and submitting PMA supplements including 30 day notice real time review 180 day supplement and annual reports Knowledge of FDA PMA guidance documents and CFR regulations Experience reviewing and approving validation and engineering study protocols and reports Experience reviewing and approving manufacturing changes

Preferred Qualifications:

Leadership or team management experience Experience working on global regulatory submissions Strong project management and documentation skills Ability to manage multiple regulatory projects simultaneously

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)