Regulatory Affairs Specialist Position Available In Cobb, Georgia

Regulatory Affairs Specialist locations
USA, Georgia, Atlanta
USA, Texas, Houston
time type
Full time
posted on
Posted 2 Days Ago
job requisition id

R0029951

Job Description:

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.

Job Title:

Regulatory Affairs Specialist Reports To:

Director, Regulatory Affairs |

Foot & Ankle Location:

Atlanta, GA or Houston, TX Business Unit Description:

Regulatory Affairs High-Level Position Summary:

We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. This role will develop regulatory strategies, complete impact assessments, and prepare submissions including

U.S. FDA 510

(k)s, EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body. Key Responsibilities The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need. Provide regulatory expertise and guidance to cross-functional teams for both new product development and sustaining projects.
Complete regulatory deliverables for assigned projects, including strategy development, impact assessments, and submission preparation through to clearance or approval.
Prepare global submissions including but not limited to

U.S. FDA 510

(k) Premarket Notifications, PMA submissions, EU MDR Technical Documentation, and other international product registrations
Collaborate with cross-functional teams to collect and review technical documentation, ensuring accuracy, regulatory compliance, and timely submissions.
Communicate and negotiate with global regulatory bodies during submission reviews, audits, and post-market activities.
Identify risks and develop contingency plans for assigned regulatory projects.
Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
Maintain regulatory databases, trackers, and documentation in accordance with internal procedures and applicable regulations.
Support compliance-related activities such as site registrations, audits, and post-market surveillance (e.g., HHEs, MDRs, FAs, CAPAs). quality system knowledge to all job functions.
Perform additional tasks as assigned by the Regulatory Manager.
Comply with Enovis’s Code of Conduct, company policies, procedures, and standards. Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Minimum Basic Qualifications:

Bachelor’s degree in a scientific discipline (e.g., biology, microbiology, chemistry, engineering, or medical technology).
Minimum 5 years of regulatory affairs experience in the medical device industry.
Proven experience preparing

U.S. FDA 510

(k) submissions.
Strong understanding of design and change control processes, regulatory assessments, and quality system requirements under ISO 13485 and FDA QSR.
Experience working cross-functionally and with regulatory agencies.

Desired Characteristics:

Experience with international registrations and submissions including EU MDR.
Knowledge of medical device labeling and associated regulations.
High attention to detail with a focus on accuracy and completeness.
Strong written and verbal communication skills.
Excellent organizational, planning, and time management abilities.
Analytical and problem-solving mindset.
Strong interpersonal and team collaboration skills.
Ability to work independently with minimal supervision.
Adaptable, proactive, and capable of leading regulatory initiatives.
Proficient in Microsoft Office, Adobe Acrobat, and Agile PLM systems.

Travel:

10% Work environment | Physical demands: Ability to sit and stand for long periods of time.

Work schedule:

Hybrid schedule is available with three days on-site. “Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes. Watch this short on creating the next generation of better together at

Enovis:

Better is… | Enovis We offer a comprehensive benefits package which includes: Medical Insurance
Dental Insurance
Vision Insurance
Spending and Savings Accounts
401(k) Plan
Vacation, Sick Leave, and Holidays
Income Protection Plans
Discounted Insurance Rates
Legal Services