Sr. Mgr, Regulatory Affairs Job Summary
Plans and prepares complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulations, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance. Supports management with regulatory programs planning and implementation of departmental strategies and policies. Job Responsibilities
Submissions, development and lifecycle maintenance:
- Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision.
- Resolves submission problem areas with team.
- Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision.
- Prepares complex expository and technical documents, logically constructed and comprehensive in content.
- Prepares documentation that is complete, accurate, and on time.
- Manages post-approval projects not requiring a global core team. Approves manufacturing process changes as appropriate. Plans and implements regulatory activities that support lifecycle management (e.g. Clinical Evaluation Report support, annual reports, changes, etc.)
- Reviews labeling and packaging components to ensure accuracy and compliance with government regulations. Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing.
- Participates in global teams and provides regulatory strategy and guidance to global product development teams.
- Under minimal supervision develops US, Canada, and EU regulatory filing strategy. Provides regulatory strategy and guidance to global product owner/project team. Makes recommendations to shape the global strategy in line with regional/commercial objectives
- Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness. Works collaboratively with cross-functional team to resolve complex project issues.
- Has recognized regulatory expertise and extensive knowledge of regulatory requirements with ability to strategically interpret and communicate requirements.
- Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
- Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.
Communications and Business Support:
- Represents department on global project teams.
- Maintains professional relationships within the regulatory groups and with functional areas outside regulatory
- Develops professional relationships with Health Authorities, when required.
- Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others.
- Conveys information on team timelines and status to supervisor.
- Delivers presentations within the Company, as required.
- Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.
- Performs peer review of complex regulatory documents.
- Provides leadership and development support to the Regulatory team.
- As appropriate, supervises and ensures training and development for Regulatory staff to ensure execution of all duties in a timely and efficient manner.
- Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.
Process and Organizational Effectiveness:
Education & Qualifications
- Provides input into development of processes to leverage the client's global processes and infrastructure and maximize efficiency and effectiveness.
- Provide input into critical metrics and management reports
- Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects
- Maintains a performance and improvement culture
- Ensure roles and responsibilities for external services within a project are clearly defined and documented
- Proactively resolve issues related to outsourced activities
- Updates and maintains appropriate SOPs for the departments.
- Education equivalent to a BS degree in a scientific field, plus 8 years' experience in regulatory affairs; or
- Education equivalent to a MS degree in a scientific field, plus 6 years' experience in regulatory affairs; or
- Education equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs
- Class II medical device experience required, Class III medical device experience preferred. Experience with HCTP and tissue-based medical devices preferred.
- Analytical thinking and problem-solving skills
- Excellent written and verbal communication skills.
- Good negotiation skills.
- Ability to work well independently and with others.
- Excellent organizational skills and attention to detail.
- Ability to handle multiple projects simultaneously and maintain flexibility.
- Experience with Adobe Acrobat, Excel, Power Point, and Word, and ability to learn new computer programs.
- Ability to understand and use technical documents, such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.
- Critical thinking skills and ability to follow-through.
- In-depth knowledge of US medical device regulations as well as significant knowledge of Canadian and EU regulations.
- Ability to demonstrate leadership in job performance by example.
- Ability to function in a regulated environment and handle confidential data.
- Ability to lead and motivate others.
- Ability to meet deadlines; take initiative and make decisions within department/company guidelines.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.