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Senior Regulatory Affairs Specialist

3 months ago

Huntersville, North Carolina, United States Shelby American Inc. Full time
The Senior Regulatory Affairs Specialist will ensure compliance with all regulatory requirements for medical devices and pharmaceutical products.
This role demands a solid understanding of the regulatory landscape and navigating complex processes.

This individual will bring a sense of importance to cross-functional teams supporting global programs and maintaining effective communication with business partners worldwide.

This is a full-time position in Harrisburg, NC until early 2024, transitioning to our new facility in Huntersville, NC.

Responsibilities:
- Develop and implement regulatory strategies for medical devices and pharmaceutical products.
- Stay updated on the latest regulatory requirements and industry changes.
- Prepare and submit regulatory filings to authorities like FDA, EMA, and other global bodies.
- Review and approve labeling, promotional materials, and product claims for regulatory compliance.
- Collaborate with teams to ensure regulatory compliance through the product lifecycle.
- Perform regulatory assessments and offer guidance on requirements for new product development.
- Engage in agency inspections and audits.
- Deliver training on regulatory standards and processes to internal teams.
- Monitor and manage regulatory submissions and approvals.
- Coordinate regulatory activities, such as registrations and renewals.
- Provide regulatory support to R&D, Quality Assurance, and Manufacturing teams.
- Track regulatory changes and communicate their potential impact.
- Maintain regulatory documentation and records in line with company procedures and requirements.

Requirements/Qualifications:
- Bachelor's degree in a scientific field, preferably with an advanced degree.
- 4-7 years of regulatory affairs experience in the medical device and/or pharmaceutical sectors.
- Proficiency in FDA regulations, EU MDR, and other global requirements.
- Experience with regulatory submissions like 510(k), PMA, IDE, NDA, and IND.

- Familiarity with quality management systems, ISO standards, and assessing regulatory impact.

- Strong written and verbal communication skills, with the ability to convey complex regulatory information clearly.
- Detail-oriented with excellent organizational and project management abilities.
- Strong attention to detail and thrive in a fast-paced setting.
- Collaborate effectively with cross-functional teams.
- Regulatory certifications such as RAC are advantageous.

Essential Job Functions:
- Review labeling, training, and promotional materials.
- Support product and shipping release.
- Maintain FDAs GUDID database.
- Manage FDAs Drug listings and CARES Act Reporting.
- Update and review technical files.
- Review External Standards.
- Assist with government queries and registration documentation.
- Assess regulatory impacts of product changes.
- Ensure post-market regulatory compliance.
- Aid in developing and updating regulatory procedures.
- Ensure compliance with FDA and international standards.
- Support regulatory submissions, license renewals, and registrations.
- Keep up-to-date with regulatory changes and procedures.
- Provide regulatory direction to new product development teams.
- Offer customer service support.
- Drive activities to meet company objectives proactively.
- Maintain orderly regulatory files/database.
- Manage interactions with distributors, consultants, and partners.
- Perform other assigned duties and responsibilities.

Competencies:
- Excel in a dynamic medical device industry environment.
- Solid understanding of FDA, MDD, and Pharma.
- Knowledge of ISO regulations/standards and biocompatibility requirements.
- RAC certification is a bonus.
- Ability to focus on achieving milestones and contingency planning.
- Effective communication at all organizational levels.
- Strong team-working and organizational skills for overcoming obstacles and time constraints.

Physical Requirements:
- Sitting, standing, walking, listening, hand movement, grasping, and reaching.
- Vision requirements include close vision and color perception adjustments.


Mental Requirements:
- Maintain an appropriate work pace with logic, reasoning, problem-solving, and decision-making skills.
- Ability to analyze data, multi-task, and handle interruptions.
- Other Requirements: Some travel, approximately 15%.

Work Environment:
- Mostly quiet to moderate noise.

- This job description does not encompass all duties. Activities may change at any time without notice.
- An Equal Employment Opportunity and Affirmative Action employer, Safeguard Medical is committed to supporting a diverse work environment that respects all individuals based on merit only.

We believe that global success stems from diverse and inclusive teams and strive to recruit, develop, and retain talent from varied backgrounds.