Regulatory Affairs Manager - Level 1 US
4.
1 Contract 5 days ago Full Job Description Title of Position:
Regulatory Affairs Manager - Level 1 Location:
Durham/RTP area - Must be local enough to come on site 1-2 monthly as needed.
Contract Length:
9 months (renewable AND possible FTE conversion) Pay Rate:
$50-$65/hr (depending on experience) Mon-Fri; 40 hrs.
/wk.
; 8 hrs.
/day- must be flexible, may have to work some nights after 5pm and some weekends as needed.
Hybrid Work Location= Must be able to come on site 1-2 monthly as needed.
MUST HAVE MEDICAL DEVICE EXPERIENCE.
THIS IS AN ABSOLUTE MUST.
Top Skills:
High Attention to detail Comfort working w/ various internal/external stakeholders and groups.
Document Manipulation Strong word & formatting skills Veeva Vault experience would be very beneficial.
This is not a project management position!!
Job Description:
MUST HAVE MEDICAL DEVICE EXPERIENCE.
THIS IS AN ABSOLUTE MUST.
This position is responsible for providing regulatory leadership, strategic direction and support in the development, evaluation, and marketing of medical device and drug products.
This position will provide support to the Regulatory Affairs Director, Oral Health and matrixed teams as required.
Activities shall include, but not be exclusive to:
Leverage relevant regulatory knowledge and experience to help develop creative regulatory strategies, product labeling and product claims Advise and collaborate on regulatory requirements to support new product development, product modifications, product registration and regulatory submissions Plan, conduct and manage the coordination and compilation of pre and post-market regulatory submissions, and responses to regulatory agencies questions and other correspondence as needed, in accordance with regulatory agency regulations and guidelines Understand the US regulatory landscape and provide assessments of the impact of new and changing regulations Provide executive summaries and/or status updates on product/project activities to key internal/external stakeholders Identify and clearly communicate gaps or risks that may impact implementation and acts where necessary to minimize delays and anticipated difficulties Create label text drafts and review labels in accordance with local requirements Manage updates to internal regulatory databases Qualifications (Knowledge, Skills & Abilities):
5
years of direct US regulatory experience in a medical device environment Direct US regulatory experience with OTC drug products is a plus BSc or equivalent technical discipline Other professional certifications (i.
e.
RAC) a plus Ability to analyze complex oral and written governmental/regulatory positions and provide practical analysis and advice Strong technical acumen, including interpretation and documentation.
Strong knowledge of Medical Device Quality Systems (i.
e.
FDA 21 CFR 820, ISO 13485) Strong communication skills Ability to work in a team environment Proactive and self-motivated; a sense of urgency Experience with FDA databases Proficient in Microsoft Office Applications (Outlook, Word, Excel), document management systems and publishing tools 0.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 Contract 5 days ago Full Job Description Title of Position:
Regulatory Affairs Manager - Level 1 Location:
Durham/RTP area - Must be local enough to come on site 1-2 monthly as needed.
Contract Length:
9 months (renewable AND possible FTE conversion) Pay Rate:
$50-$65/hr (depending on experience) Mon-Fri; 40 hrs.
/wk.
; 8 hrs.
/day- must be flexible, may have to work some nights after 5pm and some weekends as needed.
Hybrid Work Location= Must be able to come on site 1-2 monthly as needed.
MUST HAVE MEDICAL DEVICE EXPERIENCE.
THIS IS AN ABSOLUTE MUST.
Top Skills:
High Attention to detail Comfort working w/ various internal/external stakeholders and groups.
Document Manipulation Strong word & formatting skills Veeva Vault experience would be very beneficial.
This is not a project management position!!
Job Description:
MUST HAVE MEDICAL DEVICE EXPERIENCE.
THIS IS AN ABSOLUTE MUST.
This position is responsible for providing regulatory leadership, strategic direction and support in the development, evaluation, and marketing of medical device and drug products.
This position will provide support to the Regulatory Affairs Director, Oral Health and matrixed teams as required.
Activities shall include, but not be exclusive to:
Leverage relevant regulatory knowledge and experience to help develop creative regulatory strategies, product labeling and product claims Advise and collaborate on regulatory requirements to support new product development, product modifications, product registration and regulatory submissions Plan, conduct and manage the coordination and compilation of pre and post-market regulatory submissions, and responses to regulatory agencies questions and other correspondence as needed, in accordance with regulatory agency regulations and guidelines Understand the US regulatory landscape and provide assessments of the impact of new and changing regulations Provide executive summaries and/or status updates on product/project activities to key internal/external stakeholders Identify and clearly communicate gaps or risks that may impact implementation and acts where necessary to minimize delays and anticipated difficulties Create label text drafts and review labels in accordance with local requirements Manage updates to internal regulatory databases Qualifications (Knowledge, Skills & Abilities):
5
years of direct US regulatory experience in a medical device environment Direct US regulatory experience with OTC drug products is a plus BSc or equivalent technical discipline Other professional certifications (i.
e.
RAC) a plus Ability to analyze complex oral and written governmental/regulatory positions and provide practical analysis and advice Strong technical acumen, including interpretation and documentation.
Strong knowledge of Medical Device Quality Systems (i.
e.
FDA 21 CFR 820, ISO 13485) Strong communication skills Ability to work in a team environment Proactive and self-motivated; a sense of urgency Experience with FDA databases Proficient in Microsoft Office Applications (Outlook, Word, Excel), document management systems and publishing tools 0.
Estimated Salary: $20 to $28 per hour based on qualifications.
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