Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Prepare and submit regulatory documentation for domestic and international markets ensuring compliance with applicable regulations (i.e. PMA HDE 510ks letters to file and Tech Docs).
- Provide regulatory direction to development project teams as a core team member.
- Develop regulatory strategy for new products evaluating risk of proposed strategies and offering solutions.
- Review proposed labelling for compliance with applicable global regulations.
- Review proposed product changes for impact on regulatory status of the products.
- Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides.
- Review and evaluate promotion and advertising material for compliance with applicable regulations.
- Communicate with regulatory and governmental agencies.
- May provide training and/or guidance to entry-level associates analysts interns and specialists.
- Support additional regulatory compliance items as required by regulations and as needed by the RA team.
- May provide training and/or guidance to entry-level associates analysts interns and specialists.
- Bachelors degree (or non-US equivalent) required; concentration in life sciences technical/engineering or related field preferred.
- (Preferred) Minimum of 2 years of experience in orthopaedic or medical device industry.
- (Required) A minimum of 5-7 years of experience in Regulatory Affairs Engineering Quality or related field.
- Combination of education and experience may be considered.
- Strong writing communication and interpersonal skills.
- Strong attention to detail.
- Able to multi-task and balance competing priorities and willingness to work with changing priorities.
- Knowledge of overall business environment ideally within the orthopedic industry.
- Eager to build relationships between Regulatory Affairs and other teams within the organization.
- Ability to communicate effectively at all levels.
- Advanced knowledge of FDA EU and other regulatory body regulations.
Employment Type
Full Time
