Regulatory Affairs Specialist IV
Compensation: $105,720.00 - $170,870.00 /year *
Employment Type: Full-Time
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Are you a Regulatory professional who is excited about New Product Development and Design?
If you understand premarket and 510K regulations in addition to the medical device development process, design changes and design controls, this is the position for you.
- You'll work with Program Managers and technical staff to determine action items and monitor the status of deliverables.
- Apply your experience to interpret federal/state/international regulations as they apply to our products, processes and/or procedures, and advise on the impact of regulations,while devising strategies to compliance.
- Liaison with external regulatory agencies.
- Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
- Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market companys products in that geography.
- Ensure we comply with the local regulatory requirements of the country in which the product is marketed.
- Prepare the necessary documentation, and secure necessary approvals. Respond to regulatory agency inquiries. Apply and/or write the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.
- Manage legalization, Apostille, and notarization process.
- Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
- Masters degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 7 years of experience in the offered position or related
- OR Bachelors degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 9 years of experience in the offered position or related.
SPECIAL SKILLS REQUIREMENTS:
- Establishing and implementing premarket regulatory strategy and writing and submitting premarket submissions to regulatory agencies.
- Preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
- Applying 21 CFR 803, 806 and 820 regulations.
- Communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.
- Experience with FDA audits in multiple roles (regulatory representative, back room lead, scribe, etc.) and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources.
Excellent organizational skills and attention to detail. Strong work ethic with an ability to work independently. Possess an ability to read, understand, and summarize technical and scientific information. Ability to interpret and apply regulations to company policies and procedures. Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling. Pragmatic with strong problem-solving skills. Experience working with cross-functional product development teams to ensure regulatory compliance.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.
Associated topics: attorney, attorney corporate, company, compliance office, corporate attorney, counsel, courtroom, legal, llp, market
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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