Regulatory Affairs Consultant
Regulatory Affairs Consultant
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration.
- Participate on product development teams providing regulatory strategies timelines and direction. Reviews and approves technical documentation.
- Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
- Drive product change assessments and define regulatory impact of product changes in global markets.
- Review and approve labeling training promotional and advertising material.
- Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
- Ensure compliance with U.S. FDA EU MDR/IVDR Korea MFDS China NMPA and other international medical requirements.
- Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA HHE issue assessments).
- Facilitate and prepare U.S. regulatory Pre Submission documents and pre submission meetings
- Regulatory expert support IVDR teams implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units companies government agencies as needed to develop harmonized policies procedures and work instructions for IVDR compliance
- Prepares documents vital for new product market clearance approval and continuance during product life cycle management that includes (but is not limited to) 510(k)s PM De Novo and technical files for CE marking.
- Support global regulatory registration representatives for product global registration activities
- Keep abreast of new or revised regulations guidelines points to consider compliance guides inspection reports journals meetings etc.
- Conduct trainings and/or communicate appropriate materials as needed in order to enhance teams knowledge of working in a regulated environment.
- Assist Regulatory department in the update improvement and creation of internal policies and procedures.
- Participate in business meetings with external partners as needed.
- Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.
Requirements:
- A minimum . degree in Biology Chemistry bio-engineering or related science.
- Must have a minimum of 5 years of IVD Regulatory Affairs experience.
- This experience must include either 510(k) De Novo PMA PMA supplement submissions.
- Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
- Excellent knowledge of U.S. and European/International regulations and standards.
- RAPS Regulatory Affairs Certification (RAC).
- Experience interacting with FDA and/or other regulatory agencies.
- Experience reviewing design specifications and other technical documents.
- Previous experience in EU MDD/IVDD or MDR/IVDR.
- Ability to work within a team and as an individual contributor in a fast-paced changing environment.
Employment Type
Full Time
