Regulatory Affairs Specialist

3 weeks ago

Austin, United States Enovis Full time

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

Job Title:

Regulatory Affairs Specialist

Reports To:

Director, Regulatory Affairs | Surgical

Location:

Austin Plant

Business Unit Description:

Regulatory Affairs

Role Summary:

We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Affairs Specialist will be the regulatory representative on product development teams and will be responsible for developing regulatory strategies, authoring submissions, and assessing design and manufacturing changes for wide range implantable products.

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

  • Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.

  • Develops and executes regulatory strategies for new and modified products.

  • Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.

  • Manages the release and shipment of products under regulatory controls to all regions.

  • Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.

  • Coordinates and prepares regulatory submissions for new and modified products ensuring compliance with applicable regulatory requirements and company policies.

  • Handles the preparation and processing of documentation required for new product introductions and revised products in international markets.

  • Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.

  • Provides technical guidance and regulatory training to cross-functional teams.

  • Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.

  • Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.

  • Develops and maintains procedures to ensure compliance and support business goals.

  • Maintains proficiency in government regulations and guidances.

  • Support other regulatory requests or projects as needed.

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Bachelor‘s degree with a minimum of 2 years of medical device industry experience

  • Prior experience with regulatory submissions, such as PMA or 510(k)

  • Working knowledge of FDA and international regulations for medical devices

  • General understanding of the product development process and design controls

  • Ability to manage several projects simultaneously

  • Strong interpersonal and influencing skills

  • Ability to independently manage projects, prioritize time and communicate effectively

Work environment | Physical demands:

Ability to sit and stand for long periods of time.

‘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

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, the Company‘s extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees‘ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company‘s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

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