Sr. Regulatory Affairs Specialist
Sr. Regulatory Affairs Specialist
Posted on :
14-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
14-05-2025
Job Description
Responsibilities:
- The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy conducting regulatory research producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area.
- This position reports to the Director Clinical & Regulatory Affairs.
- Collaborates as a core team member on new product development teams.
- Determines and documents appropriate regulatory strategy for proposed new products.
- Supports design control activities.
- Assesses regulatory intelligence to assist in the development of local regional and global regulatory strategies.
- Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g. concept development manufacturing marketing) to ensure product compliance.
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
- Determines requirements (local national international) and options for regulatory submission approval pathways and compliance activities.
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- Identifies the need for new regulatory procedures SOPs and participates in development and implementation.
- Helps train stakeholders on current and new regulatory requirements to ensure organizationwide compliance.
- Assists other departments in the development of SOPs to ensure regulatory compliance.
- Advises stakeholders of regulatory requirements for quality preclinical and clinical data to meet applicable regulations.
- Assesses the acceptability of quality preclinical and clinical document for submission filing to comply with applicable regulations.
- Evaluates proposed preclinical clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
- Provides regulatory information and guidance for proposed product claims/labeling.
- Ensures that the clinical and nonclinical data in conjunction with regulatory strategy are consistent with the regulatory requirements and support the proposed product claims.
- Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
- Works with crossfunctional teams for interactions with regulatory authorities including panel meetings and advisory committees.
- Supports and assists in global regulatory submissions.
- Coordinates responses to regulatory agencies as part of the submission and approval process.
- Assists with postmarket surveillance evaluation trending and reporting including updates to risk management (FMEA) process.
- Reviews labeling and promotional materials for compliance with applicable regulations and policies.
- Researches sources of regulatory information (e.g. regulatory agency websites standards organization websites literature trade sheets competitor information etc.).
- Provides department support during internal and external audits.
- Develops and maintains procedures and/or work instructions for product registrations.
- Maintains regulatory listings and registration.
- Follow written SOPs and record accurate technical data in various forms.
- Summarize and present information in written form such as memos test reports or presentation slides.
- Perform other related duties and responsibilities as assigned.
- May type on a computer using a computer mouse and computer monitor for up to 8 hours at a time.
- Work is performed in an office environment.
- Will be working in a fastpaced team environment.
- B.S. or B.A. in Science or Engineering (Biology Materials Science Chemical/Biomedical Engineering Polymer Science.
- 4 years of experience in Regulatory Affairs other work within the medical device industry or other work in a regulated industry.
Employment Type
Full Time
Key Skills
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