The posting
Job Description
The Regulatory Affairs Specialist II supports global regulatory activities throughout the product lifecycle for medical devices, in vitro diagnostics (IVDs), and life science products. The role develops and executes regulatory strategies, prepares and maintains regulatory submissions and technical documentation, manages global product registrations, and supports ongoing compliance with applicable requirements.
The Specialist II serves as a regulatory partner to cross-functional teams by providing guidance for product development, design and manufacturing changes, labeling, market expansion, and compliance initiatives. The role also supports interactions with regulatory authorities, notified bodies, international representatives, and external partners.
Responsibilities
Essential Functions & Accountabilities:
Regulatory Strategy and Product Lifecycle Management:
- Develop and support global regulatory strategies for new products, product modifications, market expansions, and lifecycle management activities.
- Assess the regulatory impact of product, manufacturing, supplier, labeling, and quality system changes, and define required actions.
- Provide regulatory input during product development, including applicable requirements, testing needs, submission pathways, and anticipated approval or clearance timelines.
- Monitor evolving regulations, standards, and regulatory expectations and communicate potential business or product impacts to stakeholders.
Regulatory Submissions and Registrations:
- Prepare, compile, review, submit, and maintain regulatory submissions and supporting documentation for product approvals, clearances, registrations, renewals, and amendments.
- Author or support U.S. FDA 510(k) submissions and Q-Submissions; EU MDR/IVDR technical documentation; Health Canada license applications and amendments; and international registrations and product notifications.
- Respond to questions, requests for additional information, and deficiencies issued by regulatory authorities and notified bodies.
- Coordinate submission content, testing requirements, deliverables, and timelines with internal stakeholders and external partners.
Technical Documentation and Regulatory Records:
- Create, review, update, and maintain technical documentation, design dossiers, registration records, licenses, certificates, and regulatory databases.
- Ensure regulatory documentation remains accurate, current, traceable, and compliant throughout the product lifecycle.
- Maintain visibility to global registrations and market authorizations, including applicable renewal and expiration requirements.
- Support documentation readiness for regulatory inspections, notified body audits, and internal audits.
Regulatory Compliance and Change Management:
- Participate in change control activities and evaluate proposed changes for regulatory impact, reporting requirements, and implementation constraints.
- Review and approve product labeling and other regulated documentation, as assigned.
- Develop and maintain regulatory procedures, work instructions, protocols, and best practices.
- Partner with Quality and cross-functional teams to address compliance issues and complete regulatory corrective and preventive actions arising from audit or inspection findings.
Regulatory Authority and External Partner Interaction:
- Interface with regulatory authorities, notified bodies, international representatives, distributors, and external regulatory partners regarding submissions, registrations, and compliance activities.
- Support regulatory inspections, external audits, technical reviews, and follow-up activities.
- Collaborate with in-country representatives and regulatory partners to obtain and maintain product registrations and licenses.
Cross-Functional Collaboration:
- Partner with Research and Development, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and other functions to integrate regulatory requirements into business and product activities.
- Communicate regulatory requirements, risks, dependencies, and timelines clearly to stakeholders.
- Lead or participate in regulatory meetings, project teams, continuous improvement initiatives, and other assigned projects.
Travel:
- Remote-based with occasional travel to CSI locations or Regulatory meetings, conferences, and audits.
Qualifications
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) preferred.
- Experience interfacing directly with the U.S. FDA, notified bodies, Health Canada, or other regulatory authorities.
- Working knowledge of FDA regulations and guidance, EU MDR/IVDR, Health Canada Medical Device Regulations, global registration processes, and ISO 13485 quality management systems.
Core Competencies :
- Strong technical writing, document review, and records management skills.
- Sound regulatory judgment, analytical thinking, and problem-solving ability.
- Effective project management, prioritization, and organizational skills.
- Ability to manage multiple priorities and work independently in a deadline-driven environment.
- Clear communication and effective collaboration with cross-functional and global stakeholders.
Experience:
- Three to five years of Regulatory Affairs experience preferred, ideally within the medical device, in vitro diagnostic, biotechnology, or life sciences industry.
- Experience preparing or supporting U.S., EU MDR/IVDR, Health Canada, and international regulatory submissions.
- Experience maintaining technical documentation, product registrations, and regulatory compliance throughout the product lifecycle.
- Experience with regulatory change assessments, labeling reviews, authority questions, audits, inspections, or corrective and preventive actions is preferred.
Education:
- Bachelor's degree in Regulatory Affairs, Engineering, Biological Sciences, Chemistry, Life Sciences, or a related scientific discipline.
An equivalent combination of education, training, and relevant experience may be considered.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected].
The good faith estimate of the salary range for this role is $80,434 to $107,245. The actual amount offered is determined by a number of factors including but not limited to location, skills and experience.
