Apply on Employer Site

Corza Medical · 2 days ago

Sr. Regulatory Affairs Specialist, Wound Closure - Remote

United States

Full-time

Remote

Senior Level

$100K/yr - $108K/yr

5+ years exp

Corza Medical is dedicated to supporting surgical providers with exceptional products and services. The Senior RA Specialist is responsible for preparing regulatory submissions and ensuring compliance for new and existing products while providing mentorship to junior staff.

MedicalMedical Device

No H1B

Responsibilities

Assist in the implementation of company’s domestic and international regulatory submission strategies

Manage multiple concurrent projects, balancing competing priorities and deadlines

Develop and maintain submission trackers, readiness matrices, and compliance checklists to ensure operational efficiency

Troubleshoot regulatory challenges and provide practical solutions to keep projects on track

Provide mentorship and guidance to junior RA staff, fostering professional growth and team collaboration

Review critical documents to assure completeness, and with supervision, will prepare responses to routine in-country representative or regulatory agency results

Ensure the content, organization and overall quality of all regulatory documentation are adequate and sufficient to comply with local, regional and / or international regulatory requirements, commitments and agreements

Development of tracking documents and follow-up to assure submissions are managed appropriately

Perform the coordination and preparation of document package for regulatory submissions (US and international)

Compile all materials required in submissions, license renewal and annual registrations

Keep abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters

Represent regulatory affairs on project teams

Develop and recommend strategies for earliest possible approvals of device applications

Generate departmental procedures

Ensure documents are apostilled, certified and legalized or notarized, as required

Assess new and / or modified standards, regulations and / or laws and determine applicability to the organization and / or product

Complete other related duties as required

Conduct oneself consistent with company standards at all times during work hours or when acting as a representative of the company

Qualification

Regulatory AffairsMedical Device RegulationsProject ManagementQuality AssuranceWound Care ProductsMentoringEffective CommunicationDetail Oriented

Required

Bachelor's degree in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology, Chemistry or related field

Minimum 5 years of experience in Regulatory Affairs in the medical device industry

Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America

Demonstrated success managing multiple projects and competing priorities in a fast-paced environment

Experience mentoring or supervising junior staff

Ability to communicate effectively both verbally and written. Effective and influential when working on teams, with solid negotiation skills when required to reach optimal decisions

Ability to work on multiple scenarios of diverse scope where analysis of a situation or data requires evaluation of various factors

Detail oriented with the ability to accomplish objectives with minimal supervision

Travel Requirements – 15%+

In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time