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CooperCompanies · 3 months ago

Regulatory Affairs Specialist II

United States

Full-time

Remote

Entry, Mid Level

$75K/yr - $100K/yr

2+ years exp

CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Regulatory Affairs Specialist II oversees the regulation process for products requiring regulatory agency licensing and creates submissions for medical devices for approval in various regions. This role involves coordinating technical information, interacting with regulatory bodies, and ensuring compliance with international regulations.

Medical Device

Responsibilities

Responsible for performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW)

Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets

Responsible for the interactions with the FDA, the EU Notified Body, and Health Canada. Keep updated on all country requirements and changes

Participate in change control meetings. Review and approve requests. Notify Regulatory Bodies of changes that impact clearances, licenses, etc

Perform labeling reviews/approvals as required

Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions

Create and maintain registrations procedures/protocols

Work closely with internal and external customers to achieve success

Additional duties and/or modifications to job description may occur at any time

Create 510(k) submissions for Domestic Market (FDA). Submit Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed

Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking

Review and Maintain (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentation after receiving CE Marking

Create New License Submissions, Amendments, and Fax Back applications for Health Canada

Respond to questions from regulatory agencies during review/submissions

Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies

Complete Regulatory Corrective and Preventive Actions generated from audit findings

Develop and maintain policies and procedures regarding to regulatory submissions and processes

Create and maintain, a foreign registration database of all current in country registrations and licenses

Partnering with International regulatory contacts to understand requirements for product registrations for new and modified products

Partnering with International regulatory contacts to plan, develop and submit product registration applications for new, modified products and/or registration renewals

Coordinate with applicable stakeholders, to support submissions and testing requirements

Attend and/or lead Regulatory meetings

Qualification

Regulatory Affairs510(k) SubmissionsTechnical FilesFDA InteractionsEU MDR RegulationsHealth Canada SubmissionsRAC CertificationSoft Skills

Required

Minimum 2-5 years of Regulatory Experience

Minimum 4 years of 510(k)/Technical File Experience

Minimum 2 years of FDA/EU submissions and interactions

Bachelor's degree (B. A./B.S.) from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience

Knowledge and understanding of US, EU MDR and international medical device regulations

Preferred

RAC certification

Benefits

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off for vacation

Personal, sick and holidays

Multiple other perks and benefits

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958

San Ramon, California, US

10001+ employees