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Regulatory Affairs Consultant

Location: Hybrid (Dallas, TX Preferred)

Yrs of Exp: 3 yrs +

Overview:  

We are seeking a highly skilled and detail-oriented Regulatory Consultant to join our dynamic team in the medical device sector. This role will provide expert guidance on navigating complex regulatory landscapes, ensuring compliance with global medical device regulations, and facilitating market entry strategies. The ideal candidate will have extensive experience in regulatory affairs within the medical device industry, with a focus on preparing submissions, maintaining compliance, and providing strategic advice to internal stakeholders.

Responsibilities:

Regulatory Strategy Development:  

Develop and implement regulatory strategies for medical devices, ensuring compliance with global regulations (FDA, EU MDR, Health Canada, TGA, etc.).

Advise on the appropriate regulatory pathways (e.g., 510(k), PMA, CE marking) based on device classification and target markets.

Regulatory Submissions & Documentation:  

Prepare and review regulatory submission documents, including 510(k) notifications, PMA applications, CE technical files, clinical evaluation reports (CERs), and other regulatory filings for various markets.

Ensure timely and accurate submission of documents to relevant regulatory bodies.

Device Classification & Risk Assessment:  

Work with cross-functional teams to classify devices according to relevant regulatory frameworks (FDA, EU, etc.).

Conduct risk assessments to determine the appropriate level of regulatory oversight required.

Compliance and Quality Systems:  

Ensure company’s products meet all regulatory requirements, including adherence to quality management standards such as ISO 13485 and FDA QSR (Quality System Regulations).

Conduct gap analysis and recommend improvements to existing systems.

- Clinical Evaluation & Trial Support:  

Provide guidance on the design, implementation, and regulatory requirements for clinical trials to support safety and efficacy claims.

Ensure clinical data meets the regulatory standards required for submission. - Labeling and Documentation Compliance:  

Review labeling, packaging, and instructions for use (IFU) to ensure they comply with regulatory requirements and accurately reflect product claims.

Advise on the regulatory impact of any changes to labeling.

- Post-Market Surveillance:  

Support post-market surveillance activities, including adverse event reporting, vigilance reporting (e.g., MDR in Europe), and periodic reviews of product performance in the market.

Assist in the preparation of periodic regulatory updates and renewals.

- Regulatory Audits and Inspections:  

Assist in preparing for and supporting regulatory inspections and audits by agencies such as FDA, EMA, and Notified Bodies.

Act as a liaison with regulatory authorities during inspections, responding to queries and providing necessary documentation.

- Global Regulatory Affairs:  

Provide guidance on the regulatory requirements for entry into international markets, ensuring timely and successful product registrations in regions such as the EU, Canada, Asia-Pacific, and Latin America.

- Training & Education:  

Conduct internal training sessions on regulatory requirements, trends, and best practices for medical devices.

Provide guidance to cross-functional teams (e.g., R&D, marketing, manufacturing) on regulatory matters.

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Qualifications:

- Education:  

  - Bachelor’s degree in Life Sciences, Engineering, or a related field (required). Advanced degree (e.g., Master’s, PhD, or Regulatory Affairs Certification (RAC)) is a plus.

- Experience:  

- Minimum of 3 years of experience in regulatory affairs, specifically within the medical device industry. Experience with both Class I, II, and III devices is preferred.

- Proven track record of successful regulatory submissions and approvals (e.g., FDA 510(k), PMA, CE marking).

- Experience with international regulations (e.g., EU MDR, TGA, Health Canada) and global market access strategies.

- Technical Skills:  

- In-depth knowledge of regulatory requirements for medical devices (FDA, EU MDR, Health Canada, etc.).

- Familiarity with ISO 13485 and other quality management system standards.

- Strong understanding of clinical trial design and the role of clinical data in regulatory submissions.

- Proficient in regulatory software tools and databases.

- Communication Skills:  

- Excellent written and verbal communication skills. Ability to write clear and concise regulatory documents and reports.

- Strong presentation and interpersonal skills, with the ability to interact with regulatory authorities, internal teams, and external partners.

- Problem Solving:  

- Strong analytical and problem-solving abilities, with attention to detail and the ability to interpret complex regulations.

- Ability to think strategically and provide creative solutions to regulatory challenges.

- Other:  

- Knowledge of international standards and best practices (e.g., GxP, ICH guidelines).

- Ability to work independently as well as in cross-functional teams.

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Preferred Qualifications:

- Regulatory Affairs Certification (RAC) from RAPS or similar certification.

- Experience with software as a medical device (SaMD) or diagnostic devices.

- Familiarity with emerging regulations such as the EU IVDR or FDA’s Digital Health initiatives.

- Multilingual skills are a plus, especially for global market access.