Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Remote

Our mission

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

Our brand promise

We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

• Remarkable service: A seamless, personal process designed around you and your needs.
• Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
• Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
  
  

Our people promise

Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

• The Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist position is responsible for preparing regulatory submissions and registration documentation, providing quality and timely regulatory support to obtain marketing clearance/approval for new products and maintaining marketability of existing products.
  
  

What you will do

• Assist in the implementation of company’s domestic and international regulatory submission strategies.
• Compile required documents from source areas for submission.
• 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.
  
  

What You Will Need

• Bachelor’s degree in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology, Chemistry or related field.
• Minimum 3+ 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.
• Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred.
• Experience with Wound Care products preferred.
• Ability to communicate effectively both verbally and written. Effective and influential when working on teams, with solid negotiation skills when required to reach optimal decision.
• 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%+
  
  

What we value

• Customer First - We deliver extraordinary experiences.
• Accountability - We do what we say.
• Integrity - We do what is right.
• Inspired - We love what we do.
• One Global Team -We before me, always.
  
  

Join us today and Excel@Corza !

Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.

Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.