Senior Regulatory Affairs Specialist - Huntersville, United States - Shelby American Inc

Shelby American Inc Huntersville, United States

5 days ago

Description

The Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products.

This position requires a deep understanding of the regulatory landscape and the ability to navigate complex regulatory processes.

This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide.

This is a full-time onsite role in Harrisburg, NC until early 2024 when the position will be located in our brand new Huntersville, NC facility.

Responsibilities:
Develop and implement regulatory strategies for medical devices and pharmaceutical products.
Stay up-to-date with the latest regulatory requirements and changes in the industry.
Prepare and submit regulatory submissions to regulatory authorities, including FDA, EMA, and other global regulatory bodies.
Review and approve labeling, promotional materials, and product claims to ensure compliance with regulations.
Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
Conduct regulatory assessments and provide guidance on regulatory requirements for new product development.
Participate in regulatory agency inspections and audits.
Provide training and guidance to internal teams on regulatory requirements and processes.
Monitor and track regulatory submissions and approvals.
Coordinate and manage regulatory activities, including product registrations, renewals, and variations.
Provide regulatory support and guidance to internal stakeholders, including R&D, Quality Assurance, and Manufacturing.
Monitor and assess changes in regulations and communicate potential impact to the organization.
Maintain regulatory documentation and records in accordance with company procedures and regulatory requirements.
Requirements

Qualifications:
Bachelor's degree in a scientific or related field. Advanced degree preferred.
Minimum of 4-7 years of experience in regulatory affairs for medical devices and/or pharmaceutical products.
Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.
Experience with regulatory submissions, including 510(k), PMA, IDE, NDA, and IND.
Strong understanding of the product development process and ability to assess regulatory impact.
Familiarity with quality management systems and ISO standards.

Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical stakeholders.

Detail-oriented with strong organizational and project management skills.
Strong attention to detail and ability to work in a fast-paced environment.
Ability to collaborate effectively with cross-functional teams.
Regulatory certifications (RAC) are a plus.
Essential Job Functions
Review labeling, training, and promotional material.
Support product and shipping release.
Maintenance of FDA's GUDID database.
Maintenance of FDA's Drug listings and CARES Act Reporting.
Technical file update and reviews.
Review of External Standards.
Support business with government queries and registration documentation requirements.
Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy.
Support post market regulatory compliance activities for US/International product approvals.
Assist with the development and maintenance of regulatory affairs department procedures.
Comply with applicable FDA and international regulatory laws/standards.
Ensure relevant ISO and FDA Export requirements are met, as required.
Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Compiles all materials to support submissions, license renewal and annual registrations.
Keeps abreast of regulatory procedures and changes.
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
Customer Service Support.
Proactively drive activities to meet and/or exceed company objectives.
Maintain regulatory files/database and chronologies in good order.

Manage interactions with distributors, consultants, and/or partners.
Perform other related duties and responsibilities as assigned.

Competencies

Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.

Knowledge of FDA, MDD, EU MDR.
Knowledge of Pharma.
ISO regulations/standards, including ISO requirements for biocompatibility).
RAC certification is a plus.
Ability to focus and achieve scheduled milestones, including contingency planning.
Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.

Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.

Physical Requirements
Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.
Mental Requirements

This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.

Other Requirements
Some travel, approximately 15%
Work Environment
The noise level in the work environment is usually quiet to moderate.
This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.
Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.

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